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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006028
First received: July 5, 2000
Last updated: May 24, 2013
Last verified: March 2003
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: January 2001
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006028

  Hide Study Locations
Locations
United States, California
Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612-3864
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Ellis Fischel Cancer Center
Indianapolis, Indiana, United States, 46285
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Tuft-New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103-1489
United States, New York
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11794-8091
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Tennessee
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75390-9032
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
CCOP - M.D. Anderson Research Base
Houston, Texas, United States, 77030-4009
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6188
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Cheryl A. Brewer, MD University of Illinois College of Medicine at Peoria
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006028     History of Changes
Other Study ID Numbers: CDR0000068041, GOG-0126L
Study First Received: July 5, 2000
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 16, 2014