Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer
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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.
PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: dexamethasone Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer |
| Enrollment: | 35 |
| Study Start Date: | May 1998 |
| Study Completion Date: | February 2004 |
| Primary Completion Date: | June 2002 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Study Chair: | Agustin Garcia, MD | USC/Norris Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003449 History of Changes |
| Other Study ID Numbers: | CDR0000066478 (5O-98-1), LAC-USC-5O981, NCI-G98-1460 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by USC/Norris Comprehensive Cancer Center:
|
recurrent ovarian epithelial cancer |
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 Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Gemcitabine |
Paclitaxel BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on June 18, 2013