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CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Primary Purpose

Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel Poliglumex
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Peritoneal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (polyglutamate paclitaxel)

Arm Description

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.

Outcomes

Primary Outcome Measures

Frequency and duration of objective response
Frequency and severity of observed adverse effects
Survival time
Duration of progression-free interval

Secondary Outcome Measures

Change in objective response
Change in observed adverse effects

Full Information

First Posted
September 6, 2002
Last Updated
July 12, 2017
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045682
Brief Title
CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Official Title
A Phase II Evaluation of CT-2103 in the Third-Line Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 15, 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (polyglutamate paclitaxel)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel Poliglumex
Other Intervention Name(s)
CT-2103, Paclitaxel Polyglutamate, PG-TXL, Xyotax
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Frequency and duration of objective response
Time Frame
5 years
Title
Frequency and severity of observed adverse effects
Time Frame
5 years
Title
Survival time
Time Frame
5 years
Title
Duration of progression-free interval
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Change in objective response
Time Frame
Baseline to 5 years
Title
Change in observed adverse effects
Time Frame
Baseline to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sabbatini
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

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