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A Randomized Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865, IND

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Trial Conditions
  • Brenner Tumor
  • Fallopian Tube Cancer
  • Malignant Ovarian Mixed Epithelial Tumor
  • Ovarian Brenner Tumor
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Stage II Ovarian Cancer
  • Stage IIA Fallopian Tube Cancer
  • Stage IIA Ovarian Epithelial Cancer
  • Stage IIA Ovarian Cancer
  • Stage IIA Primary Peritoneal Cavity Cancer
  • Stage IIB Fallopian Tube Cancer
  • Stage IIB Ovarian Cancer
  • Stage IIB Ovarian Epithelial Cancer
  • Stage IIC Fallopian Tube Cancer
  • Stage IIB Primary Peritoneal Cavity Cancer
  • Stage IIC Ovarian Cancer
  • Stage IIIA Fallopian Tube Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIC Ovarian Epithelial Cancer
  • Stage IIC Primary Peritoneal Cavity Cancer
  • Stage IIIA Primary Peritoneal Cancer
  • Stage IIIB Fallopian Tube Cancer
  • Stage IIIA Ovarian Epithelial Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Primary Peritoneal Cancer
  • Stage IIIA Primary Peritoneal Cavity Cancer
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIB Ovarian Epithelial Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIIC Primary Peritoneal Cancer
  • Stage IIIB Primary Peritoneal Cavity Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IIIC Ovarian Epithelial Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Primary Peritoneal Cancer
  • Stage IIIC Primary Peritoneal Cavity Cancer
  • Undifferentiated Ovarian Carcinoma
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Primary Peritoneal Cavity Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known whether giving paclitaxel once every three weeks is more effective than giving paclitaxel once a week. PURPOSE: This randomized phase III clinical trial is studying two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Date & Status

Suspended

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube
cancer

- FIGO stage III with > 1 cm residual ("suboptimally debulked" disease) OR FIGO
stage IV disease, defined surgically after completion of initial abdominal
surgery* NOTE: *The minimum surgery required is an abdominal surgery providing
tissue for histological evaluation and establishing and documenting the primary
site and stage, as well as a maximal effort at tumor debulking in stage III and
IV disease. If additional surgery was performed, it should have been in
accordance with appropriate surgery for ovarian and peritoneal carcinoma
described in the GOG Surgical Procedures Manual.

- The following histologic epithelial cell types are eligible:

- Serous

- Endometrioid

- Clear cell**

- Mucinous adenocarcinoma**

- Undifferentiated carcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner tumor

- Adenocarcinoma not otherwise specified

- The histologic features of the tumor must be compatible with a primary
Müllerian epithelial adenocarcinoma NOTE: **Patients with clear cell and
mucinous tumors are eligible provided there is no higher priority study.

- Co-existing fallopian tube carcinoma in situ allowed provided the primary origin of
invasive tumor is ovarian, primary peritoneal, or fallopian tube

- No current diagnosis of borderline ovarian epithelial tumor (BOET; formerly "tumors
of low malignant potential") or recurrent invasive ovarian epithelial, primary
peritoneal, or fallopian tube cancer treated with surgery only (e.g., stage Ia or Ib
low-grade ovarian epithelial or fallopian tube cancers)

- Prior diagnosis of BOET that was surgically resected and an unrelated, new
invasive cancer is diagnosed allowed provided no prior chemotherapy for ovarian
cancer was administered

- Patients will not be eligible for therapy on other clinical trials evaluating
consolidation or maintenance therapy

- No history or evidence upon physical examination of CNS disease, including primary
brain tumor, seizures not controlled with standard medical therapy, or any brain
metastases (for patients who elect to receive bevacizumab)

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm^3 (not induced or supported by granulocyte colony-stimulating factors)

- 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 during and for ≥ 6 months after
completion of study treatment

- No neuropathy (sensory or motor) > CTCAE grade 1

- No synchronous primary endometrial cancer or a history of primary endometrial cancer,
unless all of the following conditions are met:

- Stage not greater than Ia

- Grade 1 or 2

- No more than superficial myometrial invasion

- No vascular or lymphatic invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesions

- No other invasive malignancies with any evidence of the cancer present within the
past 5 years except for nonmelanoma skin cancer

- No acute hepatitis or active infection that requires parenteral antibiotics

- No clinically significant cardiovascular disease, including:

- Myocardial infarction or unstable angina within the past 6 months

- NYHA class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication (this does not include
asymptomatic, atrial fibrillation with controlled ventricular rate)

- No other medical history or conditions that, in the opinion of the investigator,
should exclude participation in this study

- Patients who elect to receive bevacizumab must meet the following criteria:

- 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 for management of venous
thrombosis including pulmonary thromboembolus)

- PTT < 1.2 times ULN

- No clinically significant proteinuria (i.e., urine protein-creatinine ratio <
1.0)

- No serious non-healing wound, ulcer, or bone fracture (including a history of
abdominal fistula, gastrointestinal [GI] perforation, or intra-abdominal
abscess) within the past 28 days

- Patients with granulating incisions healing by secondary intention with no
evidence of fascial dehiscence or infection are eligible but require weekly
wound examinations

- No active bleeding or pathologic conditions that carry high risk of bleeding
(e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)

- No metastatic tumor in the parenchyma of the liver or lungs with proximity
to large vessels that could make the patients at high risk of lethal
hemorrhage during treatment with bevacizumab (i.e., hemoptysis, liver
rupture)

- No cerebrovascular accident (e.g., stroke), transient ischemic attack, or
subarachnoid hemorrhage within the past 6 months

- No peripheral vascular disease ≥ CTCAE grade 2 (at least brief [< 24 hours]
episodes of ischemia managed non-surgically and without permanent deficit)

- No known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human or humanized antibodies

- No known allergy to cremophor or polysorbate 80

- No significant traumatic injury within 28 days before beginning bevacizumab

- No patients with clinical symptoms or signs of GI obstruction AND who require
parenteral hydration and/or nutrition

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No more than 12 weeks since diagnostic/staging surgery

- No prior cancer treatment that contraindicates study treatment

- No prior radiotherapy to any portion of the abdominal cavity or pelvis

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

- No prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant
chemotherapy for ovarian, primary peritoneal, or fallopian tube cancer

- Prior adjuvant chemotherapy for localized breast cancer allowed provided that it
was completed > 3 years ago and that the patient remains free of recurrent or
metastatic disease

- No prior targeted therapy (including, but not limited to, vaccines, antibodies,
tyrosine kinase inhibitors) or hormonal therapy for management of ovarian epithelial,
fallopian tube, or primary peritoneal cancer

- No prior therapy with any anti-VEGF drug, including bevacizumab

- No concurrent reassessment or cytoreductive surgery

- No other concurrent antineoplastic therapy including cytotoxic, biologic, hormonal,
or radiation therapy

- No concurrent thrombopoietic agents

- No concurrent amifostine or other protective agents

- Patients who elect to receive bevacizumab must meet the following criteria:

- No major surgical procedure or open biopsy within 28 days before beginning
bevacizumab

- No tissue biopsy (e.g., core biopsy) within 7 days before beginning bevacizumab

- Concurrent ovarian estrogen with or without progestin replacement therapy as
indicated at the lowest effective dose(s) for control of menopausal symptoms
allowed

- No high-dose progestins for management of anorexia while on study treatment or
before disease progression

- No concurrent major surgical procedure including, but not limited to, any of the
following:

- Abdominal surgery (laparotomy or laparoscopy) before disease progression

- Colostomy or enterostomy reversal

- Interval or secondary cytoreductive surgery

- Second-look surgery

- Concurrent heparin, lovenox, or alternative anticoagulants allowed

Gender: Female
Steward Physician(s)
  • John Chan
Facilities
  • Holy Family Hospital - Suspended
Trial Interventions
Biological
  • Bevacizumab
Drug
  • Paclitaxel
  • Carboplatin
Procedure
  • Therapeutic Conventional Surgery
  • Computed Tomography
Physician Researcher

Investigator Name:

  • John Chan

Other Information

Sponsor: Gynecologic Oncology Group
Phase: Phase 3
Trial ID: NCT01167712
Volunteers:  Not Accepting Healthy Volunteers

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