Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer - Full Text View

Sponsor:	NCIC Clinical Trials Group
Collaborator:	European Organization for Research and Treatment of Cancer - EORTC
Information provided by:	NCIC Clinical Trials Group
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Cisplatin Paclitaxel Carboplatin Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:

Progression free survival [ Time Frame: Mar 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: Mar 2008 ] [ Designated as safety issue: No ]
Response Rates [ Time Frame: March 2008 ] [ Designated as safety issue: No ]
Toxic Effects [ Time Frame: March 2008 ] [ Designated as safety issue: Yes ]
Quality of Life [ Time Frame: March 2008 ] [ Designated as safety issue: No ]
CA125 Normalization Rates [ Time Frame: March 2008 ] [ Designated as safety issue: No ]

Enrollment:	819
Study Start Date:	August 2001
Estimated Study Completion Date:	December 2013
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cisplatin, Topotecan, Paclitaxel plus Carboplatin Arm 1	Drug: carboplatin Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle Drug: cisplatin 4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle Drug: paclitaxel Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle Drug: topotecan hydrochloride 4 cycles .75mg/m2 (30 mins) days 1-5 of 21 day cycle
Active Comparator: Paclitaxel plus Carboplatin Arm 2	Drug: carboplatin Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle Drug: paclitaxel Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle

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, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Nova Scotia
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
Niagara Health System
St. Catharines, Ontario, Canada, L2R 7C6
Regional Cancer Program of the Hopital Regional
Sudbury, Ontario, Canada, P3E 5J1
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Prince Edward Island
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4

Sponsors and Collaborators

NCIC Clinical Trials Group

European Organization for Research and Treatment of Cancer - EORTC

Investigators

Study Chair:	Paul J. Hoskins, MD	British Columbia Cancer Agency
Study Chair:	Ignace B. Vergote, MD, PhD	U.Z. Gasthuisberg

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Ralph Meyer, M.D, NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:	NCT00028743 History of Changes
Other Study ID Numbers:	OV16, CAN-NCIC-OV16, EORTC-55012, GEICO-0101, CDR0000069129
Study First Received:	January 4, 2002
Last Updated:	October 28, 2011
Health Authority:	Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:

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:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms

Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
Cisplatin
Carboplatin
Paclitaxel
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators

ClinicalTrials.gov processed this record on February 09, 2012