Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer

Recruiting in Palo Alto (17 mi)

+63 other locations

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Gynecologic Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known whether chemotherapy alone is more effective than chemotherapy plus peripheral stem cell transplantation for ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with that of carboplatin, mitoxantrone, and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have persistent stage III or stage IV ovarian epithelial cancer.

Research Team

Stephen L. Graziano, MD

Principal Investigator

State University of New York - Upstate Medical University

William P. McGuire, MD

Principal Investigator

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Kenneth B. Miller, MD

Principal Investigator

Tufts Medical Center Cancer Center

Patrick J. Stiff, MD

Principal Investigator

Loyola University

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial carcinoma including the following cellular diagnoses: Serous adenocarcinoma Mucinous adenocarcinoma Endometrioid adenocarcinoma Clear cell adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Stage III (optimal or suboptimal) must be surgically reassessed OR Stage III (suboptimal) or stage IV clinically reassessed after induction chemotherapy For stage III surgical reassessment: No more than 12 weeks between end of chemotherapy and reassessment surgery AND No more than 6 weeks between reassessment surgery and randomization Patients treated on protocol GOG-158 are eligible At least a partial response to chemotherapy as defined as: Microscopic disease documented at reassessment surgery for patients optimally debulked (disease no greater than 1 cm) after primary surgery Suboptimally debulked disease (greater than 1 cm) after primary surgery and 1 of the following: Negative reassessment laparotomy Only microscopic disease at reassessment surgery Gross residual disease no greater than 1 cm at reassessment surgery prior to debulking Clinical complete response to induction chemotherapy including: - suboptimal disease Stage III or IV AND - either an abnormal CT or elevated CA-125 prior to induction chemotherapy and both are within normal limits following induction chemotherapy

PATIENT CHARACTERISTICS: Age: Under 66 Performance status: GOG 0 or 1 Hematopoietic: Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times normal Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% by MUGA No congestive heart failure Pulmonary: FEV1 and FVC at least 60% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy in the past 5 years except adequately treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or any other cancer whose prior treatment does not contraindicate this study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 and no more than 6 prior platinum-based combination chemotherapy courses (i.e., cisplatin or carboplatin) required Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior anthracycline

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Cyclophosphamide (Alkylating agents)
• Mitoxantrone (Topoisomerase II inhibitors)
• Paclitaxel (Taxane)
• Peripheral Stem Cell Transplantation (Stem Cell Transplantation)

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Veterans Affairs Medical Center - Chicago (Lakeside) Chicago, IL

Rhode Island Hospital Providence, RI

CCOP - Metro-Minnesota Saint Louis Park, MN

Veterans Affairs Medical Center - Syracuse Syracuse, NY

More Trial Locations

Who Is Running the Clinical Trial?

Gynecologic Oncology Group

Lead Sponsor

Trials

251

Patients Recruited

65,400+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Patients Recruited

153,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Patients Recruited

267,000+

Cancer and Leukemia Group B

Collaborator

Trials

81

Patients Recruited

118,000+

Southwest Oncology Group

Collaborator

Trials

389

Patients Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+