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Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms

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Trial Information

Inclusion Criteria


Inclusion Criteria

- Histologic diagnosis of ovarian cancer

- Recurrent or persistent disease following primary therapy

- Measurable disease

- Prior treatment with at least one but no more than three prior chemotherapy regimens

- Resistant or refractory to platinum-based chemotherapy

- At least 18 years of age

- Good performance status (ECOG 0 to 1)

- Adequate liver, renal and bone marrow function

Exclusion criteria

- Pregnant or currently breast feeding

- Treatment with chemotherapy or immunotherapy within four weeks

- Prior radiation to the whole pelvis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

TLK286.2003

NCT ID:

NCT00038428

Start Date:

June 2001

Completion Date:

July 2005

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
M.D. Anderson Cancer CenterHouston, Texas  77030