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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00045682
First received: September 6, 2002
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: paclitaxel poliglumex
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of CT-2103 (IND #61013) 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 ] [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Survival time [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration of progression-free interval [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in objective response [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: No ]
  • Change in observed adverse effects [ Time Frame: Baseline to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: September 2002
Primary Completion Date: February 2006 (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 polymer
  • PG-TXL
  • polyglutamate paclitaxel
  • Xyotax

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045682

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Paul Sabbatini Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00045682     History of Changes
Other Study ID Numbers: GOG-0186C, NCI-2012-02493, CDR0000257039, GOG-0186C, GOG-0186C, U10CA027469
Study First Received: September 6, 2002
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014