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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003644
First received: November 1, 1999
Last updated: March 17, 2016
Last verified: March 2016
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: carboplatin
Drug: paclitaxel
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 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Recurrence-free interval [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 571
Study Start Date: October 1998
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Genders 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
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: NCT00003644

  Show 151 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Southwest Oncology Group
Investigators
Study Chair: Robert S. Mannel, MD University of Oklahoma College of Medicine
Study Chair: David S. Alberts, MD University of Arizona
  More Information

Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00003644     History of Changes
Other Study ID Numbers: GOG-0175  NCI-2012-02291  SWOG-G0175 
Study First Received: November 1, 1999
Last Updated: March 17, 2016
Health Authority: United States: Federal Government

Keywords provided by 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:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2016