Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

dexamethasone

gemcitabine hydrochloride

paclitaxel

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial cancer Platinum resistant disease defined as: Progression during the most recent platinum-based chemotherapy OR Relapse less than 6 months after platinum-based chemotherapy Measurable or evaluable disease Elevated CA-125 only allowed Positive cytology only not eligible PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 3 times ULN Renal: Creatinine no greater than 2 mg/dL Neurologic: No peripheral neuropathy greater than grade 2 Other: No other serious medical illness or psychiatric conditions. PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics No prior gemcitabine No prior paclitaxel administered weekly Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Recovered from acute toxic effects secondary to prior therapy

Sites / Locations

USC/Norris Comprehensive Cancer Center and Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003449

First Posted

November 1, 1999

Last Updated

May 20, 2014

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00003449

Brief Title

Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer

Official Title

Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

May 1998 (undefined)

Primary Completion Date

June 2002 (Actual)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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. PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.

Detailed Description

OBJECTIVES: Determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine. Determine the toxic effects of this regimen in these patients. Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients. OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel). Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed until death. PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Drug

Intervention Name(s)

paclitaxel

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial cancer Platinum resistant disease defined as: Progression during the most recent platinum-based chemotherapy OR Relapse less than 6 months after platinum-based chemotherapy Measurable or evaluable disease Elevated CA-125 only allowed Positive cytology only not eligible PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 3 times ULN Renal: Creatinine no greater than 2 mg/dL Neurologic: No peripheral neuropathy greater than grade 2 Other: No other serious medical illness or psychiatric conditions. PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics No prior gemcitabine No prior paclitaxel administered weekly Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Recovered from acute toxic effects secondary to prior therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agustin Garcia, MD

Organizational Affiliation

University of Southern California

Official's Role

Study Chair

Facility Information:

Facility Name

USC/Norris Comprehensive Cancer Center and Hospital

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033-0804

Country

United States

Ovarian Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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