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

This study has been completed.
Sponsor:
Collaborators:
Southwest Oncology Group
Medical Research Council
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00011986
First received: March 3, 2001
Last updated: March 17, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Primary Peritoneal Carcinoma
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Drug: Paclitaxel
Drug: Carboplatin
Drug: Gemcitabine Hydrochloride
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Drug: Topotecan Hydrochloride
Procedure: Therapeutic Conventional Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
  • Progression-free Survival [ Time Frame: From the date of enrollment to first progression or death or last contact, if alive and progression free. ] [ Designated as safety issue: No ]
    Hazard ratio for progression free survival. All hazard ratios are expressed relative to the reference regimen: Carbo/taxol.

  • Frequency and Severity of Observed Adverse Effects Assessed by Common Toxicity Criteria Version 2.0 [ Time Frame: Up to 9 years ] [ Designated as safety issue: Yes ]

Enrollment: 3882
Study Start Date: January 2001
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Carboplatin
Given IV
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.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Carboplatin
Given IV
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • dFdC
  • dFdCyd
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.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Carboplatin
Given IV
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Other Names:
  • doxorubicin HCl liposome
  • TLC D-99
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.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Carboplatin
Given IV
Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamtin
  • SKF S-104864-A
  • TOPO
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.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Carboplatin
Given IV
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • dFdC
  • dFdCyd
Procedure: Therapeutic Conventional Surgery
Undergo surgery

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011986

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Southwest Oncology Group
Medical Research Council
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael Bookman Gynecologic Oncology Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00011986     History of Changes
Other Study ID Numbers: GOG-0182  NCI-2012-02376  SWOG-G0182  CDR0000068467  ISRCTN41636183  MRC-ICON5  ECOG-G0182  GOG-0182  GOG-0182  U10CA027469 
Study First Received: March 3, 2001
Results First Received: February 18, 2014
Last Updated: March 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Gemcitabine
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Carboplatin
Doxorubicin
Topotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents

ClinicalTrials.gov processed this record on July 28, 2016