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


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

This study is no longer recruiting patients.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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

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.

Condition Treatment or Intervention Phase
peritoneal cavity cancer
recurrent ovarian epithelial cancer
 Drug: polyglutamate paclitaxel
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Ovarian Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Polyglutamate Paclitaxel (CT-2103) as Third-Line Treatment in Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer

Further Study Details: 

OBJECTIVES:

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.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No active bleeding

Hepatic

  • 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

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No uncontrolled hypertension
  • No uncompensated congestive heart failure
  • No symptomatic coronary artery disease
  • No myocardial infarction within the past 6 months

Other

  • 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

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow

Surgery

  • Recovered from prior surgery

Other

  • 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

Location Information


Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Paul Sabbatini, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Study ID Numbers:  CDR0000257039; GOG-0186C
Record last reviewed:  February 2005
Last Updated:  February 17, 2005
Record first received:  September 6, 2002
ClinicalTrials.gov Identifier:  NCT00045682
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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December 3, 2009



Page Updated: January 17, 2009
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