Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin

NCT ID: NCT00369954

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with carboplatin works in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to previous cisplatin or carboplatin.

Detailed Description

OBJECTIVES:

Primary

• Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with gemcitabine hydrochloride and intraperitoneal carboplatin.
• Evaluate the systemic and regional toxicity of this regimen in these patients.

Secondary

• Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal carboplatin on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• No disease recurrence within 6 months after completion of first-line platinum-taxane therapy
• Must have undergone laparoscopy or laparotomy for either of the following:

• Second-look surgery after a complete response to first-line therapy

• No negative second-look surgery
• Secondary cytoreductive surgery for recurrent disease ≥ 6 months after completion of first-line chemotherapy
• No greater than 1 cm residual disease at the completion of laparoscopy or laparotomy AND no diffuse carcinomatosis
• Disease must be confined to the peritoneal cavity

• Retroperitoneal disease ≤ 1 cm at the completion of prior surgery allowed
• Not a candidate for a higher priority GOG protocol
• No tumors of low malignant potential

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Neuropathy (sensory and motor) ≤ grade 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection requiring antibiotics
• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
• No extensive intra-abdominal adhesions

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior surgery or chemotherapy
• No prior intraperitoneal therapy
• No prior gemcitabine hydrochloride
• No more than 1 prior regimen (including consolidation chemotherapy) for ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
• No radiotherapy to > 25% of marrow-bearing areas
• No prior abdominal-pelvic radiotherapy
• No prior cancer treatment that would preclude study therapy
• No other prior therapy directed at the malignant tumor, including biological agents (unless this was part of front-line therapy), immunologic agents, vaccines, second-line chemotherapy, or hormonal therapy

• Concurrent hormone replacement therapy allowed
• No concurrent amifostine or other protective reagents

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Gynecologic Oncology Group

Principal Investigators

Noelle G. Cloven, MD

Role: STUDY_CHAIR

Methodist Estabrook Cancer Center

Other Identifiers

GOG-0102H

Identifier Type: -

Identifier Source: secondary_id

CDR0000496764

Identifier Type: -

Identifier Source: org_study_id