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A Phase II Evaluation Of CT-2103 (IND #61013) In The Third-Line Treatment Of Recurrent Or Persistent Epithelial Ovarian or Primary Peritoneal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation Of CT-2103 (IND #61013) In The Third-Line Treatment Of Recurrent Or Persistent Epithelial Ovarian or Primary Peritoneal Cancer


OBJECTIVES:

- 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.

- 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.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

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

- At least 3 weeks since prior biological therapy or immunotherapy directed at the
malignancy

Chemotherapy

- See Disease Characteristics

- No prior polyglutamate paclitaxel (CT-2103)

- Recovered from prior chemotherapy

Endocrine therapy

- At least 1 week since prior hormonal therapy directed at the malignancy

- Concurrent hormone replacement therapy allowed

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000257039

NCT ID:

NCT00045682

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • primary peritoneal cavity cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009