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

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00045682
Collaborator
National Cancer Institute (NCI) (NIH)
78
Enrollment
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Paclitaxel Poliglumex
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2002
Actual Primary Completion Date :
Jul 15, 2006

Arms and Interventions

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.

Drug: Paclitaxel Poliglumex
Given IV
Other Names:
  • CT-2103
  • Paclitaxel Polyglutamate
  • PG-TXL
  • Xyotax

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Frequency and duration of objective response [5 years]

    2. Frequency and severity of observed adverse effects [5 years]

    3. Survival time [5 years]

    4. Duration of progression-free interval [5 years]

    Secondary Outcome Measures

    1. Change in objective response [Baseline to 5 years]

    2. Change in observed adverse effects [Baseline to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gynecologic Oncology Group Philadelphia Pennsylvania United States 19103

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Paul Sabbatini, Gynecologic Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynecologic Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00045682
    Other Study ID Numbers:
    • GOG-0186C
    • NCI-2012-02493
    • CDR0000257039
    • GOG-0186C
    • GOG-0186C
    • U10CA027469
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 13, 2017
    Last Verified:
    Jul 1, 2017
    Additional relevant MeSH terms:
    Carcinoma
    Recurrence
    Paclitaxel
    Albumin-Bound Paclitaxel
    Paclitaxel poliglumex

    Study Results

    No Results Posted as of Jul 13, 2017