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Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00023907
Enrollment
Unknown
Registered
2003-07-09
Start date
2001-07-31
Completion date
Unknown
Last updated
2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer, primary peritoneal cavity cancer

Brief summary

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.

Detailed description

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.

Interventions

DRUGpaclitaxel

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026