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Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: March 3, 2001   Last Updated: July 21, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborators: National Cancer Institute (NCI)
Southwest Oncology Group
Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00011986
  Purpose

RATIONALE: 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.

PURPOSE: 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
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: topotecan hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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 National Cancer Institute (NCI):

Study Start Date: January 2001
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 surgery Patients 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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

    • Germ cell tumors
    • Sex cord-stromal tumors
    • Carcinosarcomas
    • Mixed Mullerian tumors or carcinosarcomas
    • Metastatic carcinomas from other sites to the ovary
    • Low malignant potential tumors, including micropapillary serous carcinomas
    • 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

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • 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

Surgery:

  • See Disease Characteristics
  • No more than 12 weeks since prior surgical resection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011986

  Show 127 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Southwest Oncology Group
Medical Research Council
Investigators
Study Chair: Michael A. Bookman, MD Fox Chase Cancer Center
Investigator: William P. McGuire, MD Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Study Chair: Amy D. Tiersten, MD Herbert Irving Comprehensive Cancer Center
Study Chair: Helen Pearce, PhD Medical Research Council
  More Information

Additional Information:
Publications:
Bookman MA: GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-5002, 256s, 2006.
Bookman MA, Brady MF, McGuire WP, Harper PG, Alberts DS, Friedlander M, Colombo N, Fowler JM, Argenta PA, De Geest K, Mutch DG, Burger RA, Swart AM, Trimble EL, Accario-Winslow C, Roth LM. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a Phase III Trial of the Gynecologic Cancer Intergroup. J Clin Oncol. 2009 Mar 20;27(9):1419-25. Epub 2009 Feb 17.
Bookman MA, Greer BE, Ozols RF. Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG 158) and an update on GOG0 182-ICON5. Int J Gynecol Cancer. 2003 Nov-Dec;13(6):735-40.
Copeland LJ, Bookman M, Trimble E; Gynecologic Oncology Group Protocol GOG 182-ICON5. Clinical trials of newer regimens for treating ovarian cancer: the rationale for Gynecologic Oncology Group Protocol GOG 182-ICON5. Gynecol Oncol. 2003 Aug;90(2 Pt 2):S1-7.
Krivak TC, Darcy KM, Tian C, et al.: Relationship between ERCC1 polymorphisms, disease progression, and survivalin GOG0182, a Gynecologic Oncology Group phase III trial of platinum-based chemotherapy in women with advanced stage epithelial ovarian or primary peritoneal cancer. [Abstract] J Clin Oncol 26 (Suppl 15): A-5540, 2008.
Darcy KM, Tian C, Ambrosone CB, et al.: A Gynecologic Oncology Group study of associations between polymorphisms in ABC transporter genes (ABCB1, ABCC2, and ABCG2) and outcome in advanced stage epithelial ovarian cancer treated with platinum and taxane chemotherapy. [Abstract] J Clin Oncol 27 (Suppl 15): A-5567, 2009.
Baysal BE, DeLoia JA, Willett-Brozick JE, Goodman MT, Brady MF, Modugno F, Lynch HT, Conley YP, Watson P, Gallion HH. Analysis of CHEK2 gene for ovarian cancer susceptibility. Gynecol Oncol. 2004 Oct;95(1):62-9.

Study ID Numbers: CDR0000068467, GOG-0182, SWOG-G0182, MRC-ICON5, ECOG-G0182, ISRCTN41636183
Study First Received: March 3, 2001
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00011986     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Gemcitabine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Abdominal Neoplasms
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009