Ovarian Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00006028

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 31 Locations for this study

See Locations Near You

Community Hospital of Los Gatos
Los Gatos California, 95032, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Ellis Fischel Cancer Center
Indianapolis Indiana, 46285, United States
Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda Maryland, 20892, United States
Tuft-New England Medical Center
Boston Massachusetts, 02111, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
Cooper Hospital/University Medical Center
Camden New Jersey, 08103, United States
State University of New York Health Science Center at Brooklyn
Brooklyn New York, 11203, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook New York, 11794, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
University of Oklahoma College of Medicine
Oklahoma City Oklahoma, 73190, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Brookview Research, Inc.
Nashville Tennessee, 37203, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75390, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
CCOP - M.D. Anderson Research Base
Houston Texas, 77030, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Norwegian Radium Hospital
Oslo , N-031, Norway

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00006028

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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