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Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
This study is ongoing, but not recruiting participants.
First Received: November 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: AGO Ovarian Cancer Study Group
Collaborators: European Organization for Research and Treatment of Cancer
NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006453
  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. It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.


Condition Intervention Phase
Ovarian Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1999
Detailed Description:

OBJECTIVES:

  • Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine.
  • Compare response rate, duration of response, and survival time of patients treated with these regimens.
  • Compare the toxicity of these treatment regimens in these patients.
  • Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
  • Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study.

Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy

    • Evidence of recurrence or progression 6 months after discontinuation of prior first-line platinum-containing regimen
  • No tumor of borderline malignancy
  • Evaluable disease outside previously irradiated area
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Not specified

Renal:

  • Glomerular filtration rate greater than 50 mL/min

Other:

  • No concurrent active infection
  • No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
  • No other concurrent serious systemic disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior platinum-based chemotherapy regimen
  • No prior gemcitabine
  • No other concurrent cytotoxic or antineoplastic treatment

Endocrine therapy:

  • At least 3 weeks since prior hormonal therapy
  • Concurrent hormone replacement therapy allowed
  • Concurrent steroid antiemetics allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy (limited to the small pelvis)
  • Concurrent palliative radiotherapy to nontarget lesions allowed

Surgery:

  • See Disease Characteristics

Other:

  • At least 3 weeks since other prior investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006453

  Hide Study Locations
Locations
United States, Minnesota
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
Canada
Lions Gate Hospital
North Vancouver, Canada, V7L 2P9
Toronto Urology Study Group
Toronto, Canada, M6A 3B5
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Lethbridge Cancer Clinic
Lethbridge, Alberta, Canada, T1J 1W5
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
Nanaimo Cancer Clinic
Nanaimo, British Columbia, Canada, V9S 2B7
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada, B1P 1PS
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Algoma District Medical Group
Sault Sainte Marie, Ontario, Canada, P6B 1Y5
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Grand River Regional Cancer Centre
Kitchner, Ontario, Canada, N2G 1G3
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada, L2R 5K3
Humber River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Male Health Centre/CMX Research Inc.
Oakville, Ontario, Canada, L6H 3PI
Markham Stouffville Hospital
Markham, Ontario, Canada, L3P 7T3
Hamilton and Disrict Urology Association
Hamilton, Ontario, Canada, L8N 1T8
North York General Hospital, Ontario
North York, Ontario, Canada, M2E 1K1
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Peterborough Oncology Clinic
Peterborough, Ontario, Canada, K9H 7B6
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada, L4M 6M2
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Scarborough Hospital - General Site
Scarborough, Ontario, Canada, M1P 2V5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
William Osler Health Centre
Brampton, Ontario, Canada, L6W 2Z8
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, Canada, M5S 1B6
York County Hospital
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Prince Edward Island
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, Canada, H2W 1T8
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada, J6E 6J2
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, Canada, G1S 4L8
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, Canada, G7H 5H6
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Hotel Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8
Kells Medical Research Group Inc.
Pointe Claire, Quebec, Canada, H9R 4S3
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
L'Hotel Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
AGO Ovarian Cancer Study Group
European Organization for Research and Treatment of Cancer
NCIC Clinical Trials Group
Investigators
Study Chair: Jacobus Pfisterer, MD University Hospital Schleswig-Holstein - Kiel Campus
Study Chair: Angel J. Lacave, MD, PhD Hospital Universitario Central de Asturias
Study Chair: Marie Plante, MD Centre Hospitalier Universitaire de Quebec
  More Information

Additional Information:
Publications:
Pfisterer J, Plante M, Vergote I, et al.: Gemcitabine/carboplatin (GC) vs. carboplatin (C) in platinum sensitive recurrent ovarian cancer (OVCA). Results of a Gynecologic Cancer Intergroup randomized phase III trial of the AGO OVAR, the NCIC CTG and the EORTC GCG. [Abstract] J Clin Oncol 22 (14 Suppl): A-5005, 450s, 2004.
Pfisterer J, Vergote I, Du Bois A, Eisenhauer E; AGO-OVAR,; NCIC CTG; EORTC GCG. Combination therapy with gemcitabine and carboplatin in recurrent ovarian cancer. Int J Gynecol Cancer. 2005 May-Jun;15 Suppl 1:36-41.
Vergote I, Plante M, Richter B, et al.: Improved progression free survival (PFS) and quality of life (QOL) in a randomised study comparing gemcitabine/carboplatinum (GC) vs. carboplatin (C) in platinum sensitive ovarian cancer (OVCA). [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-155, 45, 2004.
Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, Wagner U, Stahle A, Stuart G, Kimmig R, Olbricht S, Le T, Emerich J, Kuhn W, Bentley J, Jackisch C, Luck HJ, Rochon J, Zimmermann AH, Eisenhauer E; AGO-OVAR; NCIC CTG; EORTC GCG. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol. 2006 Oct 10;24(29):4699-707. Epub 2006 Sep 11.

Study ID Numbers: CDR0000067993, AGOSG-OVAR-2.5, CAN-NCIC-OV15, EORTC-55005, EU-20064, NCI-V00-1601
Study First Received: November 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006453     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer

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

ClinicalTrials.gov processed this record on November 27, 2009