Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N2
- Tom Baker Cancer Centre
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Kelowna, British Columbia, 캐나다, V1Y 5L3
- BCCA - Cancer Centre for the Southern Interior
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North Vancouver, British Columbia, 캐나다, V7L 2L7
- Lions Gate Hospital
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Surrey, British Columbia, 캐나다, V3V 1Z2
- BCCA - Fraser Valley Cancer Centre
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Vancouver, British Columbia, 캐나다, V5Z 4E6
- BCCA - Vancouver Cancer Centre
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3E 0V9
- CancerCare Manitoba
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New Brunswick
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Moncton, New Brunswick, 캐나다, E1C 6Z8
- The Moncton Hospital
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Saint John, New Brunswick, 캐나다, E2L 4L2
- Atlantic Health Sciences Corporation
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, 캐나다, AIB 3V6
- Dr. H. Bliss Murphy Cancer Centre
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 1V7
- QEII Health Sciences Center
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kingston, Ontario, 캐나다, K7L 5P9
- Cancer Centre of Southeastern Ontario at Kingston
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Kitchener, Ontario, 캐나다, N2G 1G3
- Grand River Regional Cancer Centre
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London, Ontario, 캐나다, N6A 4L6
- London Regional Cancer Program
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Ottawa, Ontario, 캐나다, K1H 8L6
- Ottawa Health Research Institute - General Division
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St. Catharines, Ontario, 캐나다, L2R 7C6
- Niagara Health System
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Sudbury, Ontario, 캐나다, P3E 5J1
- Northeast Cancer Center Health Sciences
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Thunder Bay, Ontario, 캐나다, P7B 6V4
- Thunder Bay Regional Health Science Centre
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Toronto, Ontario, 캐나다, M5G 2M9
- Univ. Health Network-Princess Margaret Hospital
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Windsor, Ontario, 캐나다, N8W 2X3
- Windsor Regional Cancer Centre
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Prince Edward Island
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Charlottetown, Prince Edward Island, 캐나다, C1A 8T5
- PEI Cancer Treatment Centre,Queen Elizabeth Hospital
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Quebec
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Montreal, Quebec, 캐나다, H4J 1C5
- Hôpital du Sacré-Cœur de Montréal
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Montreal, Quebec, 캐나다, H2L 4M1
- CHUM - Hopital Notre-Dame
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Quebec City, Quebec, 캐나다, G1R 2J6
- CHUQ-Pavillon Hotel-Dieu de Quebec
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Sherbrooke, Quebec, 캐나다, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
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Saskatchewan
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Regina, Saskatchewan, 캐나다, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Cisplatin, Topotecan, Paclitaxel plus Carboplatin
Arm 1
|
Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle
4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle
Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle
4 cycles .75mg/m2 (30 mins) days 1-5 of 21 day cycle |
|
활성 비교기: Paclitaxel plus Carboplatin
Arm 2
|
Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle
Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Progression free survival
기간: Mar 2008
|
Mar 2008
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
전반적인 생존
기간: 2012년 12월
|
2012년 12월
|
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Response Rates
기간: March 2008
|
March 2008
|
|
Toxic Effects
기간: March 2008
|
March 2008
|
|
Quality of Life
기간: March 2008
|
March 2008
|
|
CA125 Normalization Rates
기간: March 2008
|
March 2008
|
공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Paul J. Hoskins, MD, British Columbia Cancer Agency
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OV16
- CAN-NCIC-OV16 (기타 식별자: PDQ)
- EORTC-55012 (기타 식별자: EORTC)
- GEICO-0101 (기타 식별자: GEICO)
- CDR0000069129 (기타 식별자: PDQ)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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