Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy

Ovarian Cancer Clinical Trial

Official title:

Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006028
• Other study ID #: CDR0000068041
• Secondary ID: GOG-0126L
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: May 24, 2013
• Start date: January 2001

Study information

• Verified date: March 2003
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.

Description:

OBJECTIVES:

• Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols.

• Determine the nature and degree of toxicity of this regimen in this patient population.

• Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients.

• Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma

• Recurrent or persistent disease

• Bidimensionally measurable disease by physical examination or medical imaging techniques

• Sonography is acceptable if lesions are clearly defined on initial examination and bidimensionally measurable

• Ascites and pleural effusions are not considered measurable disease

• Must not be eligible for a higher priority Gynecologic Oncology Group protocol

• Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease

• Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment

• If no prior paclitaxel, a second regimen containing paclitaxel allowed

• Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy)

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• Sensory and motor neuropathy no greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic or immunologic therapy for ovarian or peritoneal cancer

Chemotherapy:

• See Disease Characteristics

• No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens

• No prior gemcitabine

• At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and recovered

Endocrine therapy:

• At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer

• Concurrent continuation of hormonal replacement therapy allowed

Radiotherapy:

• At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and recovered

• No prior radiotherapy to only site of measurable disease

• No prior radiotherapy to more than 25% of bone marrow

Surgery:

• See Disease Characteristics

• At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered

Other:

• At least 3 weeks since other prior therapy for ovarian or peritoneal cancer

• No prior cancer treatment that would preclude study

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

Locations

Country	Name	City	State
Norway	Norwegian Radium Hospital	Oslo
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Tuft-New England Medical Center	Boston	Massachusetts
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	University of Texas Medical Branch	Galveston	Texas
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	CCOP - M.D. Anderson Research Base	Houston	Texas
United States	Ellis Fischel Cancer Center	Indianapolis	Indiana
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Norway, 

References & Publications (1)

Brewer CA, Blessing JA, Nagourney RA, Morgan M, Hanjani P. Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Nov;103(2):446-50. Epub 2006 Apr 27. — View Citation