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Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT00011986
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 19, 2016
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Southwest Oncology Group
Medical Research Council
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE March 3, 2001
First Posted Date  ICMJE January 27, 2003
Results First Submitted Date  ICMJE February 18, 2014
Results First Posted Date  ICMJE April 19, 2016
Last Update Posted Date April 16, 2019
Study Start Date  ICMJE January 2001
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Overall Survival [ Time Frame: Up to 9 years ]
    Proportion of participants whose overall survival exceeded 5 years.
  • Progression-free Survival [ Time Frame: From the date of enrollment to first progression or death or last contact, if alive and progression free. ]
    Median duration in months of progression free survival.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00011986 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 [ Time Frame: Up to 9 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Official Title  ICMJE A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
Brief Summary Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.
Detailed Description

OBJECTIVES:

Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine, doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free survival, in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma.

Determine the response rate in patients with measurable disease treated with these regimens.

Compare the toxic effects of these regimens in these patients. Compare the complications in patients treated with these regimens. Determine the dose-intensity and cumulative dose delivery for these regimens in these patients.

OUTLINE:

This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery: Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for surgery Stratum B: Suboptimal residual disease without plans for surgery Stratum C: Suboptimal residual disease with plans for surgeryPatients are randomized to 1 of 5 treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues as in arm I. Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I. Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months.

PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Peritoneal Carcinoma
  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer
Intervention  ICMJE
  • Drug: Paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • TAX
  • Drug: Carboplatin
    Given IV
  • Drug: Gemcitabine Hydrochloride
    Given IV
    Other Names:
    • dFdC
    • dFdCyd
  • Drug: Pegylated Liposomal Doxorubicin Hydrochloride
    Other Names:
    • doxorubicin HCl liposome
    • TLC D-99
  • Drug: Topotecan Hydrochloride
    Given IV
    Other Names:
    • Hycamtin
    • SKF S-104864-A
    • TOPO
  • Procedure: Therapeutic Conventional Surgery
    Undergo surgery
Study Arms  ICMJE
  • Active Comparator: Arm I
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Experimental: Arm II
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Gemcitabine Hydrochloride
  • Experimental: Arm III
    Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Pegylated Liposomal Doxorubicin Hydrochloride
  • Experimental: Arm IV
    Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Topotecan Hydrochloride
  • Experimental: Arm V
    Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Gemcitabine Hydrochloride
    • Procedure: Therapeutic Conventional Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2018)
4312
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 28, 2013
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma
  • The following are ineligible:

    • Germ cell tumors
    • Sex cord-stromal tumors
    • Carcinosarcomas
    • Mixed Mullerian tumors or carcinosarcomas
    • Metastatic carcinomas from other sites to theovary
    • Low malignant potential tumors, including micropapillary serouscarcinomas
    • Mucinous primary peritoneal carcinoma
  • Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
  • Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
  • Prior breast cancer allowed provided the following are true:

    • Disease-free for more than 5 years
    • No prior cytotoxic chemotherapy for breast cancer
  • Prior or concurrent primary endometrial cancer allowed if the following conditions are met:

    • Stage no greater than IB
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • No acute hepatitis
  • Creatinine no greater than 1.5 times ULN
  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No greater than grade 1 sensory or motor neuropathy
  • No active infection that requires antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No severe or ongoing gastrointestinal bleeding that requires blood product support
  • See Disease Characteristics
  • Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true:

    • More than 3 years since prior therapy
    • No evidence of recurrent disease
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true:

    • More than 3 years since prior therapy
    • No evidence of recurrent disease
  • See Disease Characteristics
  • No more than 12 weeks since prior surgical resection
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Italy,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00011986
Other Study ID Numbers  ICMJE GOG-0182
NCI-2012-02376 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-G0182
CDR0000068467
ISRCTN41636183
MRC-ICON5
ECOG-G0182
GOG-0182 ( Other Identifier: Gynecologic Oncology Group )
GOG-0182 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE
  • Southwest Oncology Group
  • Medical Research Council
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Michael Bookman Gynecologic Oncology Group
PRS Account Gynecologic Oncology Group
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP