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Clinical Trial: CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study is no longer recruiting patients.
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 CT-2103 in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| peritoneal cavity cancer recurrent ovarian epithelial cancer | Drug: polyglutamate paclitaxel Procedure: chemotherapy | Phase II |
MedlinePlus related topics: Ovarian Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Polyglutamate Paclitaxel (CT-2103) as Third-Line Treatment in Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer
OBJECTIVES:
- Determine the antitumor activity of polyglutamate paclitaxel (CT-2103) as third-line treatment for patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive polyglutamate paclitaxel (CT-2103) IV over 10-20 minutes on day 1. Courses repeat every 21 days 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: A total of 19-51 patients will be accrued for this study within 11-22 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer after second-line therapy
- Received 1 prior platinum-based first-line chemotherapy regimen and 1 prior second-line (non-platinum, non-taxane) chemotherapy regimen
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- At least 1 target lesion that has not previously been irradiated
- Ineligible for a higher priority GOG protocol (if one exists)
- Ineligible for the currently active phase II cytotoxic protocol for platinum-resistant disease
PATIENT CHARACTERISTICS: Age
- 18 and over
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
- No active bleeding
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
- PT or PTT less than ULN
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No uncontrolled hypertension
- No uncompensated congestive heart failure
- No symptomatic coronary artery disease
- No myocardial infarction within the past 6 months
Other
- No sensory or motor neuropathy greater than grade 1
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy
- At least 3 weeks since prior biological therapy or immunotherapy directed at the malignancy
Chemotherapy
- See Disease Characteristics
- No prior polyglutamate paclitaxel (CT-2103)
- Recovered from prior chemotherapy
Endocrine therapy
- At least 1 week since prior hormonal therapy directed at the malignancy
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy directed at the malignancy
- No prior therapy for another malignancy that would preclude this study
- No concurrent amifostine or other protective reagents
Location Information
Iowa
Holden Comprehensive Cancer Center, Iowa City, Iowa, 52242-1009, United States
Texas
University of Texas - MD Anderson Cancer Center, Houston, Texas, 77030-4009, United States
Paul Sabbatini, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Record last reviewed: February 2005
Last Updated: February 17, 2005
Record first received: September 6, 2002
ClinicalTrials.gov Identifier: NCT00045682
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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