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

NCT ID: NCT00045682

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30

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.

Conditions

Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paclitaxel Poliglumex

Intervention Type: DRUG

Given IV

Interventions

Paclitaxel Poliglumex

Given IV

Intervention Type: DRUG

Other Intervention Names

CT-2103; Paclitaxel Polyglutamate; PG-TXL; Xyotax

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Sabbatini

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02493

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000257039

Identifier Type: -

Identifier Source: secondary_id

GOG-0186C

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0186C

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0186C

Identifier Type: -

Identifier Source: org_study_id