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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Trial of Intravenous Gemcitabine (NSC #613327) and Intraperitoneal Carboplatin (NSC # 241240) in the Treatment of Patients With Platinum-Sensitive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma With Non-Measurable Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00369954
• Other study ID #: CDR0000496764
• Secondary ID: GOG-0102H
• Status: Withdrawn
• Phase: Phase 2
• First received: August 29, 2006
• Last updated: June 7, 2013
• Start date: April 2006

Study information

• Verified date: October 2007
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

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

• Persistent or recurrent disease

• Nonmeasurable disease

• Platinum-sensitive disease

• Must have attained a clinically defined complete response after prior platinum- (cisplatin or carboplatin) and taxane-based combination chemotherapy regimen

• Patients with partial response or disease progression after first-line therapy are not eligible

• 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• carboplatin

• gemcitabine hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative risk of progression-free survival			No
Primary	Frequency and severity of observed adverse effects by CTCAE version 3.0			Yes
Secondary	Relative risk of survival			No