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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-NCIC-OV16 | Other Identifier | PDQ | |
| EORTC-55012 | Other Identifier | EORTC | |
| GEICO-0101 | Other Identifier | GEICO | |
| CDR0000069129 | Other Identifier | PDQ |
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| Name | Class |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
| Grupo Español de Investigación en Cáncer de Ovario | OTHER |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin, Topotecan, Paclitaxel plus Carboplatin | Active Comparator | Arm 1 |
|
| Paclitaxel plus Carboplatin | Active Comparator | Arm 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Mar 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Dec 2012 | |
| Response Rates | March 2008 | |
| Toxic Effects |
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DISEASE CHARACTERISTICS:
Histologically confirmed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
Fine needle aspiration showing an adenocarcinoma is allowed instead of open or true-cut biopsy if the following are true:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent biological response modifiers or immunotherapy
No concurrent prophylactic colony-stimulating factors (CSFs)
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J. Hoskins, MD | British Columbia Cancer Agency | Study Chair |
| Ignace B. Vergote, MD, PhD | University Hospital, Gasthuisberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada | ||
| Cross Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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| cisplatin | Drug | 4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle |
|
| paclitaxel | Drug | Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle |
|
| topotecan hydrochloride | Drug | 4 cycles .75mg/m2 (30 mins) days 1-5 of 21 day cycle |
|
| March 2008 |
| Quality of Life | March 2008 |
| CA125 Normalization Rates | March 2008 |
| Edmonton |
| Alberta |
| T6G 1Z2 |
| Canada |
| BCCA - Cancer Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Lions Gate Hospital | North Vancouver | British Columbia | V7L 2L7 | Canada |
| BCCA - Fraser Valley Cancer Centre | Surrey | British Columbia | V3V 1Z2 | Canada |
| BCCA - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| The Moncton Hospital | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Atlantic Health Sciences Corporation | Saint John | New Brunswick | E2L 4L2 | Canada |
| Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | AIB 3V6 | Canada |
| QEII Health Sciences Center | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Northeast Cancer Center Health Sciences | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston | Kingston | Ontario | K7L 5P9 | Canada |
| Grand River Regional Cancer Centre | Kitchener | Ontario | N2G 1G3 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Ottawa Health Research Institute - General Division | Ottawa | Ontario | K1H 8L6 | Canada |
| Niagara Health System | St. Catharines | Ontario | L2R 7C6 | Canada |
| Thunder Bay Regional Health Science Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Univ. Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Windsor Regional Cancer Centre | Windsor | Ontario | N8W 2X3 | Canada |
| PEI Cancer Treatment Centre,Queen Elizabeth Hospital | Charlottetown | Prince Edward Island | C1A 8T5 | Canada |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| CHUQ-Pavillon Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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