Phase
Condition
Fallopian Tube Cancer
Ovarian Cancer
Vaginal Cancer
Treatment
N/AClinical Study ID
Ages 18-75 Female
Study Summary
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
Study Description
Connect with a study center
Tom Baker Cancer Centre
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia V1Y 5L3
CanadaSite Not Available
Lions Gate Hospital
North Vancouver, British Columbia V7L 2L7
CanadaSite Not Available
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia V3V 1Z2
CanadaSite Not Available
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
CancerCare Manitoba
Winnipeg, Manitoba R3E 0V9
CanadaSite Not Available
The Moncton Hospital
Moncton, New Brunswick E1C 6Z8
CanadaSite Not Available
Atlantic Health Sciences Corporation
Saint John, New Brunswick E2L 4L2
CanadaSite Not Available
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador AIB 3V6
CanadaSite Not Available
QEII Health Sciences Center
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario K7L 5P9
CanadaSite Not Available
Grand River Regional Cancer Centre
Kitchener, Ontario N2G 1G3
CanadaSite Not Available
London Regional Cancer Program
London, Ontario N6A 4L6
CanadaSite Not Available
Ottawa Health Research Institute - General Division
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Niagara Health System
St. Catharines, Ontario L2R 7C6
CanadaSite Not Available
Northeast Cancer Center Health Sciences
Sudbury, Ontario P3E 5J1
CanadaSite Not Available
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario P7B 6V4
CanadaSite Not Available
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Windsor Regional Cancer Centre
Windsor, Ontario N8W 2X3
CanadaSite Not Available
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
Charlottetown, Prince Edward Island C1A 8T5
CanadaSite Not Available
CHUM - Hopital Notre-Dame
Montreal, Quebec H2L 4M1
CanadaSite Not Available
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec H4J 1C5
CanadaSite Not Available
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec G1R 2J6
CanadaSite Not Available
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Allan Blair Cancer Centre
Regina, Saskatchewan S4T 7T1
CanadaSite Not Available
Saskatoon Cancer Centre
Saskatoon, Saskatchewan S7N 4H4
CanadaSite Not Available

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