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Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy

Sponsor
AGO Study Group (Other)
Overall Status
Completed
CT.gov ID
NCT00006453
Collaborator
European Organisation for Research and Treatment of Cancer - EORTC (Other), NCIC Clinical Trials Group (Other)
74
Locations
85
Duration (Months)

Study Details

Study Description

Brief 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. 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 or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 1999
Actual Primary Completion Date :
Oct 1, 2006
Actual Study Completion Date :
Oct 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 St. Mary's/Duluth Clinic Health System Duluth Minnesota United States 55805
    2 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2
    3 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    4 Lethbridge Cancer Clinic Lethbridge Alberta Canada T1J 1W5
    5 British Columbia Cancer Agency - Centre for the Southern Interior Kelowna British Columbia Canada V1Y 5L3
    6 Nanaimo Cancer Clinic Nanaimo British Columbia Canada V9S 2B7
    7 Penticton Regional Hospital Penticton British Columbia Canada V2A 3G6
    8 British Columbia Cancer Agency - Fraser Valley Cancer Centre Surrey British Columbia Canada V3V 1Z2
    9 Prostate Centre at Vancouver General Hospital Vancouver British Columbia Canada V5Z 3J5
    10 British Columbia Cancer Agency Vancouver British Columbia Canada V5Z 4E6
    11 St. Paul's Hospital - Vancouver Vancouver British Columbia Canada V6Z 1Y6
    12 British Columbia Cancer Agency - Vancouver Island Cancer Centre Victoria British Columbia Canada V8R 6V5
    13 G. Steinhoff Clinical Research Victoria British Columbia Canada V8V 3N1
    14 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    15 Moncton Hospital Moncton New Brunswick Canada E1C 6ZB
    16 Doctor Leon Richard Oncology Centre Moncton New Brunswick Canada E1C 8X3
    17 Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
    18 Newfoundland Cancer Treatment and Research Foundation St. Johns Newfoundland and Labrador Canada A1B 3V6
    19 Nova Scotia Cancer Centre Halifax Nova Scotia Canada B3H 1V7
    20 Cape Breton Cancer Centre Sydney Nova Scotia Canada B1P 1PS
    21 Royal Victoria Hospital, Barrie Barrie Ontario Canada L4M 6M2
    22 William Osler Health Centre Brampton Ontario Canada L6W 2Z8
    23 Hamilton and Disrict Urology Association Hamilton Ontario Canada L8N 1T8
    24 Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario Canada L8V 5C2
    25 Kingston Regional Cancer Centre Kingston Ontario Canada K7L 5P9
    26 Grand River Regional Cancer Centre Kitchner Ontario Canada N2G 1G3
    27 London Health Sciences Centre London Ontario Canada N6A 4G5
    28 Cancer Care Ontario-London Regional Cancer Centre London Ontario Canada N6A 4L6
    29 Markham Stouffville Hospital Markham Ontario Canada L3P 7T3
    30 Trillium Health Centre Mississauga Ontario Canada L5B 1B8
    31 Credit Valley Hospital Mississauga Ontario Canada L5M 2N1
    32 York County Hospital Newmarket Ontario Canada L3Y 2P9
    33 North York General Hospital, Ontario North York Ontario Canada M2E 1K1
    34 Male Health Centre/CMX Research Inc. Oakville Ontario Canada L6H 3PI
    35 Lakeridge Health Oshawa Oshawa Ontario Canada L1G 2B9
    36 Ottawa Regional Cancer Centre Ottawa Ontario Canada K1H 1C4
    37 Peterborough Oncology Clinic Peterborough Ontario Canada K9H 7B6
    38 Algoma District Medical Group Sault Sainte Marie Ontario Canada P6B 1Y5
    39 Scarborough Hospital - General Site Scarborough Ontario Canada M1P 2V5
    40 Hotel Dieu Health Sciences Hospital - Niagara St. Catharines Ontario Canada L2R 5K3
    41 Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario Canada P3E 5J1
    42 Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario Canada P7A 7T1
    43 Toronto East General Hospital Toronto Ontario Canada M4C 3E7
    44 Toronto Sunnybrook Regional Cancer Centre Toronto Ontario Canada M4N 3M5
    45 St. Michael's Hospital - Toronto Toronto Ontario Canada M5B 1W8
    46 Mount Sinai Hospital - Toronto Toronto Ontario Canada M5G 1X5
    47 Toronto General Hospital Toronto Ontario Canada M5G 2C4
    48 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    49 Women's College Campus, Sunnybrook and Women's College Health Science Center Toronto Ontario Canada M5S 1B6
    50 Saint Joseph's Health Centre - Toronto Toronto Ontario Canada M6R 1B5
    51 Humber River Regional Hospital Weston Ontario Canada M9N 1N8
    52 Cancer Care Ontario - Windsor Regional Cancer Centre Windsor Ontario Canada N8W 2X3
    53 Queen Elizabeth Hospital, PEI Charlottetown Prince Edward Island Canada C1A 8T5
    54 Complexe Hospitalier de la Sagamie Chicoutimi Quebec Canada G7H 5H6
    55 CHUS-Hopital Fleurimont Fleurimont Quebec Canada J1H 5N4
    56 Hopital Charles Lemoyne Greenfield Park Quebec Canada J4V 2H1
    57 Centre Hospitalier Regional de Lanaudiere Joliette Quebec Canada J6E 6J2
    58 L'Hotel Dieu de Levis Levis Quebec Canada G6V 3Z1
    59 Maisonneuve-Rosemont Hospital Montreal Quebec Canada H1T 2M4
    60 Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2L-4M1
    61 McGill University Montreal Quebec Canada H2W 1S6
    62 Centre Hospitalier de l'Universite' de Montreal Montreal Quebec Canada H2W 1T8
    63 Hotel Dieu de Montreal Montreal Quebec Canada H2W 1T8
    64 Hopital Sainte Justine Montreal Quebec Canada H3T 1C5
    65 Hopital Du Sacre-Coeur de Montreal Montreal Quebec Canada H4J 1C5
    66 Kells Medical Research Group Inc. Pointe Claire Quebec Canada H9R 4S3
    67 Centre Hospitalier Universitaire de Quebec Quebec City Quebec Canada G1R 2J6
    68 Hopital du Saint-Sacrament, Quebec Quebec City Quebec Canada G1S 4L8
    69 Centre Hospitalier Regional de Rimouski Rimouski Quebec Canada G5L 5T1
    70 L'Hopital Laval Ste-Foy Quebec Canada G1V 4G5
    71 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    72 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4
    73 Lions Gate Hospital North Vancouver Canada V7L 2P9
    74 Toronto Urology Study Group Toronto Canada M6A 3B5

    Sponsors and Collaborators

    • AGO Study Group
    • European Organisation for Research and Treatment of Cancer - EORTC
    • NCIC Clinical Trials Group

    Investigators

    • Study Chair: Jacobus Pfisterer, MD, University Hospital Schleswig-Holstein
    • Study Chair: Angel J. Lacave, MD, PhD, Hospital Universitario Central de Asturias
    • Study Chair: Marie Plante, MD, Centre Hospitalier Universitaire de Quebec

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AGO Study Group
    ClinicalTrials.gov Identifier:
    NCT00006453
    Other Study ID Numbers:
    • CDR0000067993
    • AGOSG-OVAR-2.5
    • CAN-NCIC-OV15
    • EORTC-55005
    • EU-20064
    • NCI-V00-1601
    First Posted:
    Jul 28, 2003
    Last Update Posted:
    Dec 23, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by AGO Study Group
    recurrent ovarian epithelial cancer
    Additional relevant MeSH terms:
    Gemcitabine
    Carboplatin

    Study Results

    No Results Posted as of Dec 23, 2015