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Active Clinical Trials: Ovarian

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ProtocolTitle
GOG-0212
(Gynecology- Ovarian)
A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103)(IND #70177), Versus No Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Cancer Who (1186)
  • Eligibility: click to view information

    *** SPECIAL REGULATORY REQUIREMENTS NEEDED PRIOR TO PATIENT ENTRY***

    1) Histo dx of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III or IV,with either optimal or suboptimal residual disease following initial surgery.
    2) Completed tx in last 6 wks with at least 5 cycles (not more than 6 cycles) of carboplatin & paclitaxel or docetaxel-based combination chemo and have no symptoms suggestive of persistent cancer.
    3) GOG PS: 0,1 or 2
    4) No current dx of epithelial ovarian tumor of low malignant potential
    5) No germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors/carcinosarcomas, etc - see pg 11. section 3.22
    6) No prior radiotherapy to abdominal cavity or pelvis


  • HIPAA Forms: 0212 HIPAA
  • Consent Forms: 0212 NCI Consent
S. CANNON-GYN19
(Gynecology- Ovarian)
A Randomized Phase II Study of Paciltaxel/Carboplatin with or without Sorafenib in the First-Line Treatment of Patients with Stage III/IV Epilthelial Ovarian Cancer (1679)
  • Eligibility: click to view information

    Inclusion:
    *Histologically confirmed, stage III or IV epithelial ovarian carcinoma
    *No previous treatment with chemotherapy or radiation therapy
    *All patients must have undergone cytoreductive surgery, with the following results:
    a. No residual tumor nodule > 3cm
    b. No residual tumor involvement of the bowel (ie. invasion into bowel wall)
    c. No residual intestinal obstruction
    *Measurable or evaluable disease. Patients with elevated CA-125 levels and no detectable disease on radiologic evaluation will be considered to have evaluable disease.
    *ECOG PS 0 or 1
    *ANC = 1500/µL, platelets = 100,000/µL, hemoglobin = 9.0 g/dL.
    *Total bilirubin = 1.5 x upper limits of normal (ULN), ALT and AST = 2.5 x ULN (= 5 x ULN for patients with liver metastases)
    *Serum creatinine = 1.5 x ULN
    *INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR may be > 1.5, and should be measured prior to initiation of sorafenib and monitored at least weekly until INR is stable in the desired therapeutic range.

    Exclusion Criteria
    *Active cardiac disease, including: A) congestive heart failure > class II NYHA (Appendix H), B) unstable angina or onset of angina within last 3 months, C) myocardial infarction within 6 months
    *Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
    *Patients with CNS metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
    *Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic pressure > 90mmHg, despite optimal medical management
    *Known HIV, chronic hepatitis B or chronic hepatitis C infections
    *Active clinically serious infection (> grade 2)
    *Thrombotic or embolic events such as cerebral vascular accident including transient ischemic attacks within the last 6 months.
    *Pulmonary hemorrhage/bleeding event = grade 2 within 4 weeks of starting treatment.
    *Any other hemorrhage/bleeding event = grade 3 within 4 weeks of starting treatment
    *Serious non-healing wound, ulcer, or bone fracture
    *Evidence of history of bleeding diathesis or coagulopathy
    *Major surgery, open biopsy, or significant traumatic injury within 4 weeks of starting treatment.
    *Any condition that impairs the ability to swallow whole pills
    *Patients with any type of malabsorption
    *Known or suspected allergy to any of the agents used in this treatment
    *Use of St. Johns Wort or rifampin

  • Consent Forms: GYN19 Consent
GOG-0252
(Gynecology- Ovarian)
A Phase III Clinical Trial of Bevacizumab with IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma (1730)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma, including any of the following epithelial cell types*:

    Serous adenocarcinoma
    Endometrioid adenocarcinoma
    Mucinous** adenocarcinoma
    Undifferentiated carcinoma
    Clear** cell adenocarcinoma
    Mixed epithelial carcinoma
    Transitional cell carcinoma
    Malignant Brenner tumor
    Adenocarcinoma not otherwise specified NOTE: *Histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma.
    NOTE: **Patients with mucinous, low grade or clear cell disease are eligible unless there is a higher priority GOG trial open.

    Stage II, III, or IV disease with either optimal (= 1 cm residual disease) or suboptimal residual disease
    Must have undergone surgery for diagnosis, staging, and/or cytoreduction within the past 12 weeks
    Prior or concurrent primary endometrial cancer allowed provided the primary origin of the invasive tumor is ovarian or peritoneal and all of the following criteria are met:

    Stage of endometrial cancer is = IB
    No more than superficial myometrial invasion, without vascular or lymphatic invasion
    No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
    No borderline ovarian epithelial tumor ("tumors of low malignant potential") (e.g., stage IA or IB disease with low-grade lesions)

    Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive ovarian epithelial or primary peritoneal cancer are eligible provided they have not received prior chemotherapy for any ovarian tumor
    No recurrent invasive ovarian epithelial cancer treated with surgery only
    No history or evidence of major CNS disease by physical examination (e.g., primary brain tumor, metastatic cancer in the brain, seizures not controlled with standard medical therapy, or any brain metastases within the past 6 months
    No metastatic tumor in the parenchyma of the liver or lungs with proximity to large vessels
    PATIENT CHARACTERISTICS:

    GOG performance status 0-2
    ANC = 1,500/mm³ (without granulocyte colony-stimulating factor support)
    Platelet count = 100,000/mm³
    Bilirubin = 1.5 times upper limit of normal (ULN)
    AST and ALT = 2.5 times ULN
    Alkaline phosphatase = 2.5 times ULN
    Creatinine normal
    Urine protein:creatinine ratio < 1.0
    PTT < 1.5 times ULN

    Concurrent heparin, lovenox or alternative anticoagulants allowed
    PT/INR = 1.5 times ULN (or an in-range INR, usually between 2 and 3, if patient is on a stable dose of therapeutic warfarin)
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception during and for = 6 months after completion of study treatment
    No sensory or motor neuropathy > CTCAE grade 1
    No seizures not controlled with standard medical therapy
    No other invasive malignancies within the past 5 years, except nonmelanoma skin cancer
    No acute hepatitis or active infection requiring parenteral antibiotics
    No serious non-healing wound, ulcer, or bone fracture

    Granulating incisions healing by secondary intention allowed provided there is no evidence of fascial dehiscence or infection AND the wound is examined weekly during study
    No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition
    No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
    No active bleeding or pathologic condition that carries a high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)
    No cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
    No clinically significant cardiovascular disease, including any of the following:

    Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
    Myocardial infarction or unstable angina within the past 6 months
    NYHA cla

  • Consent Forms: 0252 NCI Consent
GOG 0213
(Gynecology- Ovarian)
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritone (1518)
  • Eligibility: click to view information

    Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent.

    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 had a complete response to front-line platinum-taxane therapy (at least three cycles) and a treatment-free interval without clinical evidence of progressive disease lasting at least 6 months. Front-line therapy may have included a biologic agent (i.e. bevacizumab) but an interval of at least six months must have elapsed after completion of therapy.


    A complete response to front-line chemotherapy must include: negative physical exam, negative pelvic exam, normalization of CA125, if elevated at baseline and negative radiographic assessment of disease.

    Front-line treatment may include maintenance therapy following complete clinical or pathological response. However, recurrent disease must not be identified earlier than 6 months following completion of all anti-cancer treatment.

    Patients who have undergone reassessment laparotomy or laparoscopy following primary therapy are eligible for this study as long as they demonstrated a pathologic complete response based on the surgical assessment (i.e. all obtained specimens were histologically negative for disease).

    Patients must have clinically evident measurable or non-measurable disease.
    Non-measurable disease is either symptomatic ascites or pleural effusion. Patients with clinically evident non-measurable disease must also have either:

    CA-125 > two times the ULN. Patients registered onto the study with serum CA-125 levels less than 100 U/ml must be confirmed a second time within a period of not more than 4 weeks. Patients with a level greater or equal to 100 U/ml may be entered without confirmatory measurement. The CA-125 assessment for eligibility must be done at least 4 weeks after paracentesis or other surgical procedures.

    Histologic confirmation of recurrence is required in the absence of an elevated CA-125 and measurable disease.

    Patients who are not candidates for surgical cytoreduction are eligible for the chemotherapy randomization. Patients are not considered candidates for surgical cytoreduction if complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking.

    Ineligible Patients:

    Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen).

    Patients receiving concurrent immunotherapy, or radiotherapy.

    Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded.

    Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided that they meet the criteria listed in Section 3.12.

    Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation.

    Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than five 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; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, includin

  • HIPAA Forms: 0213 HIPAA
  • Consent Forms: 0213 NCI Consent
8199
(Gynecology- Ovarian)
Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women At Increased Genetic Risk of Ovarian Cancer: Extended follow-up to GOG-0199 Study Participants (1816)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Enrolled on GOG-0199

    Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer
    Completed the Off-Study form (Form Q0-0199 submitted via SEDES)
    No patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)
    PATIENT CHARACTERISTICS:

    Not specified
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics


  • Consent Forms: 8199 Consent
N08CA
(Gynecology- Ovarian)
The Use of Glutathione (GSH) for Prevention of Paclitaxel/Carboplatin (TAXOL/CBDCA) Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind Placebo Controlled Study (Gyn Onc patients only) (1766)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Diagnosis of stage III/IV ovarian cancer, fallopian tube cancer, and/or primary peritoneal carcinoma
    Scheduled to undergo treatment with paclitaxel at 175 mg/m^2 and carboplatin at area under the curve = 6 every 21 days for 6 courses with or without bevacizumab
    PATIENT CHARACTERISTICS:

    ECOG performance status 0-2
    Life expectancy = 6 months
    WBC = 3,400/mm^3
    ANC = 1,500/mm^3
    Platelet count = 100,000/mm^3
    Hemoglobin > 10.0 g/dL
    Creatinine = 1.5 times upper limit of normal
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception
    Able to complete English language questionnaire(s) alone or with assistance
    Willing to provide blood specimens as required by the study
    No pre-existing history of peripheral neuropathy > grade 1 (NCI CTCAE v4.0) due to any cause (e.g., chemotherapy, diabetes, alcohol, toxin, or heredity)
    No other medical conditions that, in the opinion of the treating physician/allied health professional, would make this study unreasonably hazardous for the patient
    No diabetes requiring insulin or oral hypoglycemic medications
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    No prior paclitaxel or carboplatin other than the current treatment regimen
    No other concurrent treatment for the prevention of peripheral neuropathy, including prescription and over-the-counter or herbal therapies

  • Consent Forms: N08CA Consent
GOG-0126T
(Gynecology- Ovarian)
A Phase II Evaluation of Belinostat (NSC# 726630, IND# 729990) and Carboplatin (NSC #241240) in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (1768)
  • Eligibility: click to view information

    **3.182 B: Progression by radiography itself must be shown within the 6 mo window.

    DISEASE CHARACTERISTICS:

    Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma, including the following cell types:

    Serous adenocarcinoma
    Endometrioid adenocarcinoma
    Mucinous adenocarcinoma
    Undifferentiated carcinoma
    Clear cell adenocarcinoma
    Mixed epithelial carcinoma
    Transitional cell carcinoma
    Malignant Brenner tumor
    Adenocarcinoma not otherwise specified
    Received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for the management of primary disease

    Initial therapy may have included non-cytotoxic therapy, intraperitoneal therapy, high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
    Patients who have NOT received prior paclitaxel-based chemotherapy MUST receive a second regimen that includes paclitaxel or docetaxel
    Platinum-resistant or refractory disease

    Disease progressed on or within 6 months of the last platinum dose
    Development of CA125 elevation on or within 6 months of the last platinum dose, in the absence of radiographic progression according to RECIST criteria, is not considered platinum resistance for the purposes of this study
    No other additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens, except as listed above
    One additional non-cytotoxic regimen for the management of recurrent or persistent disease is allowed
    Measurable disease as defined by RECIST criteria

    Measurable disease is defined as = 1 lesion that can be accurately measured in = 1 dimension (longest dimension to be recorded)
    Each lesion must be = 10 mm when measured by CT scan, MRI, or caliper measurement by clinical exam OR = 20 mm when measured by chest x-ray
    Lymph nodes must be = 15 mm in short axis when measured by CT scan or MRI
    Must have = 1 "target lesion" to be used to assess response on this study as defined by RECIST criteria

    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 = 90 days following completion of radiotherapy
    Not eligible for a higher priority GOG trial, if one exists (e.g., any active GOG phase III trial for the same patient population)
    PATIENT CHARACTERISTICS:

    GOG performance status 0-2
    ANC = 1,500/mm^3
    Platelet count = 100,000/mm^3
    Creatinine = 1.5 times upper limit of normal (ULN)
    Bilirubin = 1.5 times ULN
    SGOT = 3 times ULN
    Alkaline phosphatase = 2.5 times ULN
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception
    No neuropathy (sensory and motor) > grade 1 according to NCI CTCAE v3.0
    No active infection requiring antibiotics (except for uncomplicated urinary tract infection)
    No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
    No significant cardiovascular disease, including any of the following:

    Unstable angina pectoris
    Uncontrolled hypertension (i.e., BP > 150/90 mm Hg despite maximal medical therapy)
    Congestive heart failure related to primary cardiac disease
    Any condition requiring antiarrhythmic therapy
    Ischemic or severe valvular heart disease
    Myocardial infarction within the past 6 months
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    Recovered from prior surgery, radiotherapy, or chemotherapy
    No prior cancer treatment that would contraindicate study treatment
    No prior belinostat or other histone deacetylase inhibitors
    No prior radiotherapy to > 25% of marrow-bearing areas
    No prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian cancer

    Prior radiotherapy for localized cancer of the breast, head and neck, or skin is allowed provided it was completed > 3 years ago AND the patient remains free of recurrent

  • Consent Forms: 0126-T Consent
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