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Completed

NCT Number: NCT00003644

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Brenner Tumor Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

Up to 120 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kagoshima City Hospital, Kagoshima City, Kagoshima, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin

Drug

paclitaxel

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)
  • SWOG Cancer Research Network

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
2010
First posted
Jan 27, 2003
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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