Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal 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.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer |
| Study Start Date: | July 2001 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent or persistent ovarian epithelial or primary peritoneal cancer
Measurable disease
At least 1 lesion measured in at least 1 dimension
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
At least 1 target lesion
- Tumors within a previously irradiated field considered non-target lesions
Paclitaxel resistant
- Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR
- Progression during prior paclitaxel-based therapy
Platinum resistant or refractory
- Treatment-free interval of less than 6 months duration after treatment with prior platinum OR
- Progression during prior platinum-based therapy
- Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No grade 2 or greater neuropathy (sensory and motor)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior biologic or immunologic agents for cancer
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy for cancer and recovered
- Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease
- Initial treatment may include high-dose therapy, consolidation, or extended therapy
- Received at least 1 prior paclitaxel-based chemotherapy regimen
- No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses
- No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
Endocrine therapy:
- At least 1 week since prior hormonal therapy for cancer
- Concurrent hormone replacement therapy allowed
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy for cancer and recovered
- No prior radiotherapy to site(s) of measurable disease
- No prior radiotherapy to more than 25% of marrow-bearing areas
Surgery:
- At least 3 weeks since prior surgery for cancer and recovered
Other:
- At least 3 weeks since other prior therapy for cancer
- No prior anticancer treatment that would preclude study
- No concurrent amifostine or other protective reagents
Contacts and Locations
Show 44 Study Locations| Study Chair: | Maurie Markman, MD | The Cleveland Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00023907 History of Changes |
| Other Study ID Numbers: | CDR0000068875, GOG-0126N |
| Study First Received: | September 13, 2001 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Gynecologic Oncology Group:
|
recurrent ovarian epithelial cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013