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Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
This study is ongoing, but not recruiting participants.
First Received: January 4, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: NCIC Clinical Trials Group
Collaborator: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028743
  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 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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: cisplatin
Drug: paclitaxel
Drug: topotecan hydrochloride
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Phase III Study of Cisplatin Plus Topotecan Followed by Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Women With Newly Diagnosed Advanced Epithelial Ovarian Cancer

Resource links provided by NLM:


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

Study Start Date: August 2001
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028743

Locations
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada, V9S 2B7
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2P9
Fraser/Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Grand River Regional Cancer Centre at Grand River Hospital
Kitchner, Ontario, Canada, N2G 1G3
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 2X3
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, Canada, L2R 5K3
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Prince Edward Island
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Hopital Notre- Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Paul J. Hoskins, MD British Columbia Cancer Agency
Investigator: Ignace B. Vergote, MD, PhD U.Z. Gasthuisberg
  More Information

Additional Information:
Publications:
Hoskins PJ, Vergote I, Stuart G, et al.: A phase III trial of cisplatin plus topotecan followed by paclitaxel plus carboplatin versus standard carboplatin plus paclitaxel as first-line chemotherapy in women with newly diagnosed advanced epithelial ovarian cancer (EOC) (OV.16). A Gynecologic Cancer Intergroup Study of the NCIC CTG, EORTC GCG, and GEICO. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5505, 2008.

Study ID Numbers: CDR0000069129, CAN-NCIC-OV16, EORTC-55012, GEICO-0101
Study First Received: January 4, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00028743     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2009