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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
carboplatin
cisplatin
paclitaxel
topotecan hydrochloride
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • BCCA - Cancer Centre for the Southern Interior
  • Lions Gate Hospital
  • BCCA - Fraser Valley Cancer Centre
  • BCCA - Vancouver Cancer Centre
  • CancerCare Manitoba
  • The Moncton Hospital
  • Atlantic Health Sciences Corporation
  • Dr. H. Bliss Murphy Cancer Centre
  • QEII Health Sciences Center
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • Cancer Centre of Southeastern Ontario at Kingston
  • Grand River Regional Cancer Centre
  • London Regional Cancer Program
  • Ottawa Health Research Institute - General Division
  • Niagara Health System
  • Northeast Cancer Center Health Sciences
  • Thunder Bay Regional Health Science Centre
  • Univ. Health Network-Princess Margaret Hospital
  • Windsor Regional Cancer Centre
  • PEI Cancer Treatment Centre,Queen Elizabeth Hospital
  • CHUM - Hopital Notre-Dame
  • Hopital du Sacre-Coeur de Montreal
  • CHUQ-Pavillon Hotel-Dieu de Quebec
  • Centre hospitalier universitaire de Sherbrooke
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cisplatin, Topotecan, Paclitaxel plus Carboplatin

Paclitaxel plus Carboplatin

Arm Description

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall Survival
Response Rates
Toxic Effects
Quality of Life
CA125 Normalization Rates

Full Information

First Posted
January 4, 2002
Last Updated
March 31, 2020
Sponsor
NCIC Clinical Trials Group
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC, Grupo Español de Investigación en Cáncer de Ovario
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1. Study Identification

Unique Protocol Identification Number
NCT00028743
Brief Title
Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 31, 2001 (Actual)
Primary Completion Date
March 5, 2008 (Actual)
Study Completion Date
January 10, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC, Grupo Español de Investigación en Cáncer de Ovario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
819 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin, Topotecan, Paclitaxel plus Carboplatin
Arm Type
Active Comparator
Arm Description
Arm 1
Arm Title
Paclitaxel plus Carboplatin
Arm Type
Active Comparator
Arm Description
Arm 2
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Description
4 cycles .75mg/m2 (30 mins) days 1-5 of 21 day cycle
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
Mar 2008
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Dec 2012
Title
Response Rates
Time Frame
March 2008
Title
Toxic Effects
Time Frame
March 2008
Title
Quality of Life
Time Frame
March 2008
Title
CA125 Normalization Rates
Time Frame
March 2008

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J. Hoskins, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ignace B. Vergote, MD, PhD
Organizational Affiliation
University Hospital, Gasthuisberg
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BCCA - Cancer Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
Facility Name
BCCA - Fraser Valley Cancer Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
The Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Dr. H. Bliss Murphy Cancer Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
AIB 3V6
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Grand River Regional Cancer Centre
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Health Research Institute - General Division
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Niagara Health System
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2R 7C6
Country
Canada
Facility Name
Northeast Cancer Center Health Sciences
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Thunder Bay Regional Health Science Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Univ. Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 8T5
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
CHUQ-Pavillon Hotel-Dieu de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
result

Learn more about this trial

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

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