Trial Search Results

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: Bevacizumab
  • Drug: Carboplatin
  • Drug: Docetaxel
  • Drug: Gemcitabine Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Drug: Paclitaxel
  • Other: Quality-of-Life Assessment

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery
   and consent to have their surgical treatment determined by randomization

   - 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)

   - A complete response to front-line chemotherapy must include: negative physical exam,
   negative pelvic exam and normalization of CA125, if elevated at baseline; although not
   required, any radiographic assessment of disease status (e.g. CT, magnetic resonance
   imaging [MRI], positron emission tomography [PET]/CT, etc) obtained following the
   completion of primary therapy should be considered negative for disease

   - All patients must have also had a treatment-free interval without clinical evidence of
   progressive disease of at least 6 months from completion of front-line chemotherapy
   (both platinum and taxane); front-line therapy may have included a biologic agent
   (i.e. bevacizumab)

   - Front-line treatment may include maintenance therapy following complete clinical or
   pathological response; however, maintenance cytotoxic chemotherapy must be
   discontinued for a minimum of 6 months prior to documentation of recurrent disease;
   patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE
   provided their recurrence is documented more than 6 months from primary cytotoxic
   chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has
   elapsed since their last infusion of biological therapy

   - Patients must have clinically evident recurrent disease for the purpose of this study

   - Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) 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 more than or equal to 20 mm
   when measured by conventional techniques, MRI or CT, or more than or equal to 10 mm
   when measured by spiral CT

   - Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to
   Common Toxicity Criteria for Adverse Events version (v)3.0 (CTCAE) grade 1

   - Platelets greater than or equal to 100,000/mm^3 (CTCAE grade 0-1)

   - Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 x institutional
   upper limit normal (ULN), CTCAE grade 1

   - Total bilirubin =< 1.5 ULN (CTCAE grade 1)

   - Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) =< 2.5
   times the upper limit of normal in the absence of liver metastasis; SGOT/AST < 5.0
   times ULN in the presence of liver metastasis

   - Alkaline phosphatase =< 2.5 times the upper limit of normal in the absence of liver
   metastasis; alkaline phosphatase < 5.0 times ULN in the presence of liver metastasis

   - This criterion applies only to the patients enrolled before August 29, 2011 and those
   enrolled after this date electing to receive bevacizumab; patients must have a urine
   protein-to-creatinine ratio (UPCR) < 1.0 mg/dL

   - This eligibility criterion does not apply to patients enrolled after August 28, 2011;
   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

   - Patients must have met the pre-entry requirements as specified

   - Patients must have signed an approved informed consent and authorization permitting
   release of personal health information

   - Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

Exclusion Criteria:

   - 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 whom have already undergone secondary cytoreduction for recurrent disease 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 above

   - 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 (other
   than ovarian, fallopian tube, and primary peritoneal) are excluded

   - 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, including papillary
   serous, clear cell or other International Federation of Gynecology and Obstetrics
   (FIGO) grade 3 lesions

   - Patients with uncontrolled infection

   - Patients with concurrent severe medical problems unrelated to the malignancy that
   would significantly limit full compliance with the study or expose the patient to
   extreme risk or decreased life expectancy

   - Patients with >= grade 2 peripheral neuropathy

   - Patients with a history of allergic reactions to carboplatin and/or paclitaxel or
   chemically similar compounds; patients with allergic (hypersensitivity) reactions to
   these chemotherapeutic agents are NOT excluded IF they were successfully retreated
   following a desensitization program or protocol

   - This criterion applies only to the patients enrolled before August 29, 2011 and those
   enrolled after this date electing to receive bevacizumab; patients with known
   hypersensitivity to Chinese hamster ovary cell products or other recombinant human or
   humanized antibodies

   - Patients of childbearing potential, not practicing adequate contraception, patients
   who are pregnant or patients who are nursing are not eligible for this trial;
   bevacizumab should not be administered to nursing women

   - Patients with other invasive malignancies, with the exception of non-melanoma skin
   cancer, 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

   - This criterion applies only to the patients enrolled before August 29, 2011 and those
   enrolled after this date electing to receive bevacizumab; patients with active
   bleeding or pathologic conditions that carry high risk of bleeding such as a known
   bleeding disorder, coagulopathy, or tumor involving major vessels

   - This criterion applies only to the patients enrolled before August 29, 2011 and those
   enrolled after this date electing to receive bevacizumab; patients with a history or
   evidence upon physical examination of central nervous system (CNS) disease, including
   primary brain tumor, seizures not controlled with standard medical therapy, any brain
   metastases or a history of stroke within 5 years of the first date of treatment on
   this study

   - This criterion applies only to the patients enrolled before August 29, 2011 and those
   enrolled after this date electing to receive bevacizumab; patients with clinically
   significant cardiovascular disease; this includes:

      - Patients with significant cardiac conduction abnormalities, i.e. PR interval >
      0.24 seconds (sec) or 2nd or 3rd degree atrioventricular (AV) block

      - Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm
      Hg

      - Myocardial infarction, cardiac arrhythmia or unstable angina < 6 months prior to
      registration

      - New York Heart Association (NYHA) grade II or greater congestive heart failure

      - Serious cardiac arrhythmia requiring medication

      - Grade II or greater peripheral vascular disease (exception: episodes of ischemia
      < 24 hours [hrs] in duration, that are managed non-surgically and without
      permanent deficit)

      - History of cerebrovascular attack (CVA) within six months

   - This criterion applies only to the patients enrolled before August 29, 2011 and those
   enrolled after this date electing to receive bevacizumab; patients who have had a
   major surgical procedure, open biopsy, dental extractions or other dental
   surgery/procedure that results in an open wound, or significant traumatic injury
   within 28 days prior to the first date of treatment on this study, or anticipation of
   need for major surgical procedure during the course of the study; patients with
   placement of vascular access device or core biopsy within 7 days prior to the first
   date of treatment on this study

   - Patients undergoing pre-treatment secondary cytoreduction will undergo therapy with
   bevacizumab on cycle #2

   - Patients undergoing pre-treatment surgery for purposes other than cytoreduction may
   also participate provided they meet eligibility; patients randomized to arms
   containing bevacizumab must wait a minimum of 28 days since that procedure to begin
   protocol treatment; patients who undergo an uncomplicated port placement must wait a
   minimum of 7 days to begin protocol treatment

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting