• be undergoing an IVF treatment cycle

• Lasts 12 weeks and includes 9 visits
• One center, open label
• Two groups of 25 subjects each
• Flexible dose (30 or 60mgs)
• FREE (meds, examinations, medical care) to all patients
• Maximal patient compensation - $100
• Additional 2 months after the study free medication treatment available
• Careful assessment performed at each visit

• Adult female (age 18 and older)
• Onset of depression within 4 weeks but at least 2 weeks after delivery
• Speak English or Spanish
• Have access to phone and her own transportation
• Provide written and verbal informed consent

• Current or lifetime psychosis
• Unstable medical condition
• Hypertension
• Substance use disorder
• Bulimia, anorexia and seizure disorder
• Any antidepressants
• Any antipsychotic medications

• Subjects will be randomized in a 2:1 fashion to weekly 17 alpha-hydroxyprogesterone caproate versus placebo. Thus 2 out of 3 patients will receive active medication.
• Treatment will continue until 36 weeks' gestation or delivery.
• Both the 17P and the placebo are supplied by Matria Healthcare at no cost to the participant.
• All other care will be coordinated by the subject's primary physician.

• Be at least 18 years old.
• Be in preterm labor between 23 and 34 weeks' gestation.
• Be admitted to the hospital and be receiving antenatal steroids for fetal well being.
• Have no contraindications to progesterone use.

• Rupture of membranes
• Major known fetal anomalies
• Cervical dilation > 4 centimeters
• Uterine anomalies
• Cervical cerclage
• Treatment during this pregnancy with progesterone after 14 weeks’ gestation (use up to 14 weeks' gestation is permitted)
• Previous admission for preterm labor
• Contraindications to tocolysis
• Coexisting maternal disease including hypertension requiring medical therapy, cancer, seizure disorder, thromboembolic disorders, liver disease.
• Patients treated with oral beta adrenergics for asthma are also excluded.

• To determine whether Xyotax(TM) (CT-2103) or paclitaxel, administered to women with advanced ovarian cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy ("consolidation/maintenance therapy") will reduce the death rate, compared to re-treatment at the time of documented disease progression.
• To determine if, in this clinical setting, Xyotax(TM) (CT-2103) produces a more favorable toxicity profile (with a particular focus on peripheral neuropathy as measured by the GOG NTX4) and superior quality-of-life.

• Patients with a histologic diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III or IV, with either optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery. All patients must have had appropriate surgery for ovarian or peritoneal carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.
• Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelialcarcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
• Patients must have completed treatment within the past 12 weeks with at least 5 cycles and not more than 8 cycles of a platinum (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer, normal CT scan of the abdomen/pelvis and normal CA-125 following this therapy.

• Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, Platelets greater than or equal to 100,000/ul.
• Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN).
• Hepatic function: Bilirubin less than or equal to 1.5 x ULN. SGOT and alkaline phosphatase less than or equal to 2.5 x ULN.
• Neurologic function: Neuropathy (sensory and motor) less than or equal to 1.
• Patients must have a GOG Performance Status of 0, 1, or 2.
• Patients must have signed an approved informed consent and HIPAA authorization.

• Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (LMP) (Borderline carcinomas) are not eligible.Patients with a prior diagnosis of a low malignant potential tumor that was surgically resected andwho subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for their ovarian LMP tumor.
• Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible.
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3years prior to registration, and the patient remains free of recurrent or metastatic disease.
• Patients who have received prior chemotherapy, investigational therapies, and/or biological therapies (i.e. Bevacizamab or Erlotinib) for any other abdominal or pelvic tumor (except as noted above) are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it wascompleted more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease.
• Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met:
• Stage not greater than I-B.
• Less than 3 mm invasion without vascular or lymphatic invasion.
• No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.
• With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
• Patients with acute hepatitis, or known chronic hepatitis.
• Patients with an active infection that requires antibiotics.
• Patients with ongoing gastrointestinal bleeding requiring blood product support.
• Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow-up.
• Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months.
• Patients are excluded who have had prior therapy with Xyotax (CT-2103).
• Patients with active bleeding or an unexplained PT or PTT > institutional upper limit normal (ULN).

• Patients must have persistent or recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression. Histologic confirmation of the original primary tumor is required.
• All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or ≥10 mm when measured by spiral CT.
• Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST (Section 8.1). Tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
• Patients must not be eligible for a higher priority GOG protocol, if one exists.  In general, this would refer to any active GOG Phase III protocol for the same patient population.
• Patients must have a GOG Performance Status of 0, 1, or 2.
• Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• Patients should be free of active infection requiring antibiotics.
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
• Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration.
• Patients must have had one prior systemic chemotherapeutic regimen for management of persistent or recurrent squamous or non-squamous cell carcinoma of the cervix. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is not counted as a systemic chemotherapy regimen.

• Patients who have uncontrolled cardiac, hepatic, renal/psychiatric disease.

• Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, stages IB2, IIA, IIB, IIIB, and IVA. (Stage IIA tumors must be greater than 4 cm.)
• Patients with negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT, PET CT, MRI or lymphadenectomy.
• Patients with adequate bone marrow function: ANC greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl.
• Patients with adequate renal function: creatinine equal to or less than 2.0 mg%.
• Patients with adequate hepatic function: bilirubin less than or equal to 1.5 x ULN and SGOT and alkaline phosphatase less than or equal to 3 x ULN.
• Patients who have signed an approved informed consent and authorization permitting release of personal health information.
• Patients with GOG Performance Status of 0, 1, 2, or 3.
• Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
• Patients who are suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiation.

• Patients who cannot be or have not been adequately clinically staged.
• Patients whose diagnosis cannot be histologically confirmed.
• Patients with lower one-third vaginal involvement (Stage IIIA).
• Patientswho have undergone hysterectomy.
• Patients with septicemia or severe infection.
• Patients with circumstances that will not permit completion of the study or required follow-up.
• Patients with other invasive malignancies.
• Patients with carcinoma of the cervical stump.
• Patients with uncontrolled hypertension.
• Patients who are pregnant or lactating.
• Patients with history of cardiovascular disease
• Patients with a known hypersensitivity to cisplatin or other platinum-containing compounds who are not eligible for a desensitization program.

• Women who are 20 years to 65 years old
• new diagnosis of ovarian cancer or endometrial cancer,
• no prior history of motion sickness, PONV, morning sickness, or /and previous chemo (other protocols),
• English speaking women, who are scheduled to receive paclitaxel and carboplatin chemotherapy for the first time.

• women who have different types of cancer,
• have prior experience of motion sickness, PONV, morning sickness, or/ and previous chemo induced N/V
• have already received chemotherapy or other chemotherapy regimen
• allergy to the adhesive tape.

Disease:

Ovarian Cancer, HIC #27640

Title:

A Randomized Placebo-Controlled Phase Ib/IIa Safety, Tolerability and Efficacy Study of Oral Phenoxodiol in Combination with Docetaxel versus Docetaxel Alone in Patients with Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Investigator:

Thomas J. Rutherford, PhD, MD

Purpose

To determine the safety and tolerability ofcombinational therapy of PXD (oral dosage form) + docetaxel in patients with recurrent ovarian cancer.

Research plan:

Patients to be randomized to two treatment schedules:

Treatment Schedule 1 – docetaxel weekly on weeks 1-3, 5-7 and 9-11 (no drug administered during last week of each treatment cycle)

Treatment Schedule 2 – oral phenoxodiol daily on weeks 1-3, 5-7 and 9-11 (no drug administered during last week of each treatment cycle) and docetaxel weekly on weeks 1-3, 5-7 and 9-11 (no drug administered during last week of each treatment cycle)

Treatment cycle = 4 weeks

Inclusion criteria:

• histologically-confirmed epithelial ovarian, fallopian, or primary peritoneal carcinoma
• undergone first-line therapy which must have included a platin and taxane
• platin/taxane sensitive (recurrence > 6 months after first-line therapy)
• experienced doubling of blood levels of CA125 in the six (6) months leading up to enrolment in the study and have CA125 levels at least two times greater than the institutional upper limit of normal values

-OR-

• have measurable disease as defined as having at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) allowing a response to be determined by the RECIST criteria. Each lesion must be ³ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or ³ 10 mm when measured by spiral CT.

Exclusion:

• patients who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the study
• patients with active infection
• patients with concurrent severe and/or uncontrolled medical disease (eg. uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.)
• patients with a history of chronic active hepatitis or cirrhosis
• patients with active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks
• patients who have not recovered from the acute effects of any prior anti-neoplastic therapy

Location:

Yale-New Haven Hospital and
Yale Physicians Building
New Haven, CT 06520

Contact:

Lisa D. Baker, RN
Office: 203 785 6398
lisa.baker@yale.edu

• Have recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer which was histologically confirmed at the time of the primary diagnosis.
• Have received one prior platinum-based chemotherapeutic regimen (containing either carboplatin or cisplatin) for the treatment of primary disease
• Considered to be potentially platinum-sensitive (i.e., have had a platinum-free interval following complete response to carboplatin or cisplatin of greater than 6 months).

• has received more than 1 prior chemotherapy regimen or a history of consolidation cytotoxic chemotherapy
• received prior treatment with HYCAMTIN
• received prior radiation therapy for ovarian cancer

• To determine if the addition of 5 concurrent cycles of Bevacizumab to 6 cycles of standard therapy (carboplatin and paclitaxel) [Arm II] reduces the death rate when compared to 6 cycles of standard therapy alone [Arm I] in women with newly diagnosed stage III-suboptimal and stage IV epithelial ovarian or peritoneal primary cancer.
• To determine if the addition of 5 concurrent cycles of Bevacizumab plus extended Bevacizumab for 16 cycles beyond the 6 cycles of standard therapy (carboplatin and paclitaxel) [Arm III] reduces the death rate when compared to 6 cycles of standard therapy [Arm I] in women with newly diagnosed stage III-suboptimal and stage IV epithelial ovarian or peritoneal primary cancer.

• Patients with a histologic diagnosis of epithelial ovarian cancer or peritoneal primary carcinoma, FIGO stage III (Appendix I) with suboptimal (> 1 cm maximal diameter any remaining lesion) residual disease or FIGO stage IV, following initial surgery and with appropriate tissue available for histologic evaluation. The minimum surgery required was an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking. If additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual.
• Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.).

Patients must have adequate:

• Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/μl,
• Platelets greater than or equal to 100,000/μl.
• Renal function: Creatinine < 1.5 x ULN.

Hepatic function:

• Bilirubin less than or equal to 1.5 x ULN.
• SGOT and alkaline phosphatase less than or equal to 2.5 x ULN.
• Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.
• Blood coagulation parameters: PT such that INR is _ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT < 1.2 times the upper limit of normal.
• Patients with a GOG Performance Status of 0, 1, or 2.
• Patients must be entered between 1 and 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction.
• Patients with measurable and non-measurable disease are eligible.
• Patients who have met the pre-entry requirements specified in Section 7.0.
• An approved informed consent and authorization permitting release of personal health information must be signed by the patient or guardian.

• Patients with clinically significant cardiovascular disease. This includes:
• Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg.
• Myocardial infarction or unstable angina < 6 months prior to registration.
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (Appendix II).
• Serious cardiac arrhythmia requiring medication. CTCAE Grade 2 or greater peripheral vascular disease.
• History of CVA within six months.
• Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
  Patients with clinically significant proteinuria. Patients must have a UPCR < 1.0 to allow participation in the study.
• Patients with or with anticipation of invasive procedures as defined below:
• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of Bevacizumab/placebo therapy
  (cycle 2).
• Major surgical procedure anticipated during the course of the study.
• Core biopsy within 7 days prior to the first date of Bevacizumab/placebo therapy (cycle 2).
• Patients with GOG Performance Grade of 3 or 4.
• Patients who are pregnant or nursing.
• Patients under the age of 18.
• Patients who have received prior therapy with any anti-VEGF drug, including Bevacizumab.
• Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition

Disease:

Ovary, Fallopian Tube and Primary Peritoneal Cancer, HIC #0404026648

Title:

PT-301, A Non-Interventional Prospective Study of the Accuracy of the Precision therapeutics, inc. ChemoResponse Assay in Patients with Recurrent epithelial ovarian, Peritoneal OR FALLOPIAN  TUBE cancer

Investigator:

Thomas J. Rutherford, MD

Purpose

To determine the accuracy of the PTI ChemoResponse
Assay in predicting clinical response to chemotherapy of patients with persistent, refractory, and recurrent epithelial ovarian, peritoneal, or fallopian tube cancer

To qualify you must:

• Patient must have documented abdominal or pelvic disease defined by physical exam, clinically significant increases in CA-125 (as defined by protocol), CT, MRI scan, or PET
• only received one or two prior chemotherapy regimens for their ovarian, peritoneal, or fallopian tube carcinoma

Exclusion

• Patient has ovarian stromal, mixed mullerian, or germ cell tumors

Location:

Gyn-Oncology Clinical Practice

Whom to contact:

Name: Lisa D. Baker, RN
Phone:(203) 785-6398
Email: lisa.baker@yale.edu

• must have received only one prior chemotherapeutic regime including a taxane/platinum
• be refractory or resistant to taxane/platinum
• have measurable disease

• have a colostomy
• taking coumadin therapy
• any unresolved bowel obstruction or diarrhea

Disease:

Ovary, Fallopian Tube and Primary Peritoneal Cancer

Title:

HIC #0702002345
Multi-Center, Randomized, Double-Blind, Phase III
Efficacy Study Comparing Phenoxodiol (Oral Dosage
Form) in Combination with Carboplatin versus
Carboplatin with Placebo in Patients with Platinum
Resistant or Platinum-Refractory Late-Stage Epithelial
Ovarian, Fallopian or Primary Peritoneal Cancer
Following at Least Second Line Platinum Therapy:
OVATURE (OVArian TUmor REsponse) study

Investigator:

Thomas J. Rutherford, MD

Purpose

Evaluation of combinational therapy of phenoxodiol(  PXD) and Carboplatinum in patients with recurrent or persistent advanced ovarian cancer.

To qualify you must:

• have recurrent or persistent ovarian cancer
• have measurable disease
• undergone at least two courses of therapy with a platinum drug and responded to the first course of platinum therapy
• have a platinum free interval of no greater than 6 months at the time of enrollment

Exclusion

• failed to show a clinical response to at least one prior course of platinum therapy
• known hypersensitivity to platinum drugs 

Length/Duration:

Open

Location:

Compensation:

none

Whom to contact:

Name: Lisa D. Baker, RN
Phone:(203) 785-6398
Email: lisa.baker@yale.edu