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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

May 23, 2008

Start Date ^ICMJE

October 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Recurrence-free interval [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Frequency and severity of adverse events [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Recurrence-free interval
Overall survival
Frequency and severity of adverse events

Change History

Complete list of historical versions of study NCT00003644 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Drug: carboplatin
Drug: paclitaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

500

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Japan

Administrative Information

NCT ID ^ICMJE

NCT00003644

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066732, GOG-175, SWOG-G0175

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)
Southwest Oncology Group

Investigators ^ICMJE

Study Chair:	Robert S. Mannel, MD	University of Oklahoma College of Medicine
Study Chair:	David S. Alberts, MD	University of Arizona

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP