Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Last updated: March 31, 2020
Sponsor: NCIC Clinical Trials Group
Overall Status: Completed

Phase

3

Condition

Fallopian Tube Cancer

Ovarian Cancer

Vaginal Cancer

Treatment

N/A

Clinical Study ID

NCT00028743
OV16
CDR0000069129
CAN-NCIC-OV16
GEICO-0101
EORTC-55012
  • Ages 18-75
  • Female

Study 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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer

  • No borderline ovarian tumors

  • Residual disease allowed

  • Fine needle aspiration showing an adenocarcinoma is allowed instead of open or true-cut biopsy if the following are true:

  • Presence of pelvic mass AND

  • Omental cake or other metastasis larger than 2 cm in the upper abdomen unless proven stage IV disease AND

  • Serum CA 125/carcinoembryonic antigen ratio at least 25 (if less than 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for primary tumor within 6 weeks of study) AND

  • Normal mammography within 6 weeks of study

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Granulocyte count at least 2,000/mm^3

  • Platelet count at least 150,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than upper limit of normal

Cardiovascular:

  • No clinically relevant atrial or ventricular arrhythmias

  • No myocardial infarction (MI) within the past 6 months (pretreatment ECG as only evidence of MI allowed)

  • No history of second- or third-degree heart blocks unless pacemaker implanted

  • History of first-degree heart block allowed

Other:

  • Not pregnant or nursing

  • Fertile patients must use effective contraception

  • No complete bowel obstruction

  • No prior allergic reaction to drugs containing Cremophor EL or compounds chemically related to study drugs

  • No condition that would preclude high-volume saline diuresis

  • No significant neurologic or psychiatric disorder that would preclude study compliance

  • No active uncontrolled infection

  • No neuropathy greater than grade 1

  • No pre-existing hearing loss greater than grade 1

  • No other concurrent serious illness or medical condition that would preclude study participation

  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biological response modifiers or immunotherapy

  • No concurrent prophylactic colony-stimulating factors (CSFs)

  • Concurrent therapeutic CSFs allowed

Chemotherapy:

  • No prior chemotherapy for ovarian cancer

  • No other concurrent cytotoxic agents

Endocrine therapy:

  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • No prior radiotherapy for ovarian cancer

Surgery:

  • No more than 6 weeks since prior planned pre-chemotherapy surgery for ovarian cancer

  • Planned interval debulking allowed

  • Concurrent second-look surgery allowed

Other:

  • No prior non-surgical therapy for ovarian cancer

  • No other concurrent investigational drug therapy

  • No other concurrent anticancer treatment

  • Concurrent enrollment on CAN-NCIC-OV13/EORTC 55971 allowed

Study Design

Total Participants: 819
Study Start date:
August 31, 2001
Estimated Completion Date:
January 10, 2013

Study Description

OBJECTIVES:

  • Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

  • Compare the overall survival of patients treated with these regimens.

  • Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens.

  • Compare the toxic effects of these regimens in these patients.

  • Compare the CA 125 normalization rates in patients treated with these regimens.

  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (65 years and under vs over 65 years), and pre-randomization surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8.

  • Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4.

Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the last course; and at 3 and 6 months after study treatment completion.

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

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 2 years.

Connect with a study center

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia V1Y 5L3
    Canada

    Site Not Available

  • Lions Gate Hospital

    North Vancouver, British Columbia V7L 2L7
    Canada

    Site Not Available

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia V3V 1Z2
    Canada

    Site Not Available

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • The Moncton Hospital

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick E2L 4L2
    Canada

    Site Not Available

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador AIB 3V6
    Canada

    Site Not Available

  • QEII Health Sciences Center

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario K7L 5P9
    Canada

    Site Not Available

  • Grand River Regional Cancer Centre

    Kitchener, Ontario N2G 1G3
    Canada

    Site Not Available

  • London Regional Cancer Program

    London, Ontario N6A 4L6
    Canada

    Site Not Available

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Niagara Health System

    St. Catharines, Ontario L2R 7C6
    Canada

    Site Not Available

  • Northeast Cancer Center Health Sciences

    Sudbury, Ontario P3E 5J1
    Canada

    Site Not Available

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario P7B 6V4
    Canada

    Site Not Available

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Windsor Regional Cancer Centre

    Windsor, Ontario N8W 2X3
    Canada

    Site Not Available

  • PEI Cancer Treatment Centre,Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island C1A 8T5
    Canada

    Site Not Available

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec H2L 4M1
    Canada

    Site Not Available

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec H4J 1C5
    Canada

    Site Not Available

  • CHUQ-Pavillon Hotel-Dieu de Quebec

    Quebec City, Quebec G1R 2J6
    Canada

    Site Not Available

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Allan Blair Cancer Centre

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan S7N 4H4
    Canada

    Site Not Available

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