- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045682
CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase II Evaluation of CT-2103 in the Third-Line Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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.
II. 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No active bleeding
- 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
- Creatinine no greater than 1.5 times ULN
- No uncontrolled hypertension
- No uncompensated congestive heart failure
- No symptomatic coronary artery disease
- No myocardial infarction within the past 6 months
- 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
- At least 3 weeks since prior biological therapy or immunotherapy directed at the malignancy
- No prior polyglutamate paclitaxel (CT-2103)
- Recovered from prior chemotherapy
- At least 1 week since prior hormonal therapy directed at the malignancy
- Concurrent hormone replacement therapy allowed
- Recovered from prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- Recovered from prior surgery
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (polyglutamate paclitaxel)
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.
|
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of progression-free interval
Time Frame: 5 years
|
5 years
|
Frequency and severity of observed adverse effects
Time Frame: 5 years
|
5 years
|
Survival time
Time Frame: 5 years
|
5 years
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Frequency and duration of objective response
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in objective response
Time Frame: Baseline to 5 years
|
Baseline to 5 years
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Change in observed adverse effects
Time Frame: Baseline to 5 years
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Baseline to 5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Sabbatini, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Carcinoma
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
- Paclitaxel poliglumex
Other Study ID Numbers
- GOG-0186C (Other Identifier: CTEP)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2012-02493 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000257039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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