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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group Identifier:
First received: September 6, 2002
Last updated: December 29, 2014
Last verified: December 2014
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 Intervention Phase
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Drug: Paclitaxel Poliglumex
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Frequency and duration of objective response [ Time Frame: 5 years ]
  • Frequency and severity of observed adverse effects [ Time Frame: 5 years ]
  • Survival time [ Time Frame: 5 years ]
  • Duration of progression-free interval [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Change in objective response [ Time Frame: Baseline to 5 years ]
  • Change in observed adverse effects [ Time Frame: Baseline to 5 years ]

Enrollment: 78
Study Start Date: September 2002
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00045682

United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Paul Sabbatini Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group Identifier: NCT00045682     History of Changes
Other Study ID Numbers: GOG-0186C
NCI-2012-02493 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0186C ( Other Identifier: Gynecologic Oncology Group )
GOG-0186C ( Other Identifier: CTEP )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: September 6, 2002
Last Updated: December 29, 2014

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017