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

NCT00028743 | Completed Phase 3 DMC

• 5 other identifiers: OV16CAN-NCIC-OV16EORTC-55012GEICO-0101CDR0000069129
• Study Type: interventional
• Target: 819
• Locations: 1 country
• Sites: 28

Brief 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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Mar 2008

Secondary Outcomes (5)

• Overall Survival

  Dec 2012

• Response Rates

  March 2008

• Toxic Effects

  March 2008

• Quality of Life

  March 2008

• CA125 Normalization Rates

  March 2008

Study Arms (2)

Cisplatin, Topotecan, Paclitaxel plus Carboplatin

ACTIVE COMPARATOR

Arm 1

Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: topotecan hydrochloride

Paclitaxel plus Carboplatin

ACTIVE COMPARATOR

Arm 2

Drug: carboplatin; Drug: paclitaxel

Interventions

carboplatin DRUG

Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle

Cisplatin, Topotecan, Paclitaxel plus Carboplatin; Paclitaxel plus Carboplatin

cisplatin DRUG

4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle

Cisplatin, Topotecan, Paclitaxel plus Carboplatin

paclitaxel DRUG

Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle

Cisplatin, Topotecan, Paclitaxel plus Carboplatin; Paclitaxel plus Carboplatin

topotecan hydrochloride DRUG

4 cycles .75mg/m2 (30 mins) days 1-5 of 21 day cycle

Cisplatin, Topotecan, Paclitaxel plus Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• Grupo Español de Investigación en Cáncer de Ovario: collaborator

Study Sites (28)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

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

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeast Cancer Center Health Sciences

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2R 7C6, Canada

Location

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

PEI Cancer Treatment Centre,Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Cisplatin; Paclitaxel; Topotecan

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Paul J. Hoskins, MD

  British Columbia Cancer Agency

  STUDY CHAIR

• Ignace B. Vergote, MD, PhD

  University Hospital, Gasthuisberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: August 31, 2001
• Primary Completion: March 5, 2008
• Study Completion: January 10, 2013
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (28)