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Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003644
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 17, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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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 may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: carboplatin Drug: paclitaxel Phase 3

Detailed Description:

OBJECTIVES:

  • Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel.
  • Assess the frequency and severity of toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks.
  • Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma
Study Start Date : October 1998
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Carboplatin, paclitaxel, low dose paclitaxel
carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later
 Drug: carboplatin
Drug: paclitaxel
Active Comparator: Carboplatin, paclitaxel
carboplatin, paclitaxel
 Drug: carboplatin
Drug: paclitaxel


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Up to 5 years ]
    The percent of participants with disease recurrence within 5 years

  2. Overall Survival [ Time Frame: up to 96 months ]
    Number of deaths during study and follow up.

  3. Number of Participants With Adverse Events Grade 3 or Greater [ Time Frame: Throughout study treatment lasting up to 24 weeks ]
    Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants


Eligibility Criteria
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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types:

    • Serous adenocarcinoma
    • Malignant Brenner's tumor
    • Mucinous adenocarcinoma
    • Endometrioid
    • Adenocarcinoma
    • Clear cell adenocarcinoma
    • Undifferentiated carcinoma
    • Transitional cell
    • Mixed epithelial carcinoma
    • Adenocarcinoma - not otherwise specified

  • Meets 1 of the following criteria:

    • Stage Ia or Ib, grade 3 or clear cell
    • Stage Ic or II, all grades/histologies
  • Complete surgical staging
  • No tumors of low malignant potential (borderline tumors)

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-3

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 3 times normal
  • SGOT no greater than 3 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
  • No major systemic medical illness expected to affect survival
  • Body surface area no greater than 2.0

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No prior treatment for this malignancy except surgical staging
  • No prior anticancer therapy that would preclude study participation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003644


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Southwest Oncology Group
Investigators
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Study Chair: Robert S. Mannel, MD University of Oklahoma College of Medicine
Study Chair: David S. Alberts, MD University of Arizona
More Information
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Publications of Results:

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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00003644    
Other Study ID Numbers: GOG-0175
NCI-2012-02291
SWOG-G0175
First Posted: January 27, 2003    Key Record Dates
Results First Posted: April 17, 2019
Last Update Posted: June 4, 2019
Last Verified: March 2016
Keywords provided by GOG Foundation ( Gynecologic Oncology Group ):
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
ovarian undifferentiated adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian serous cystadenocarcinoma
 ovarian mucinous cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian clear cell cystadenocarcinoma
Brenner tumor
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action