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Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms

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Trial Information

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

Inclusion Criteria


Inclusion Criteria

- Histologically or cytologically confirmed diagnosis of epithelial cancer of the
ovary, fallopian tube, or primary peritoneal cancer

- Recurrent ovarian cancer or persistent disease following primary treatment

- At least one, but no more than four, prior chemotherapy regimens (all
platinum-containing counted as one)

- At least 18 years of age

Exclusion Criteria

- Pregnant or lactating women

- History of prior malignancy except for adequately treated carcinoma in situ of the
uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which
patient has been disease-free for at least 2 years

- Known leptomeningeal metastases or carcinomatous meningitis

- Having received whole pelvis radiation therapy

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:

TLK286.2018

NCT ID:

NCT00051948

Start Date:

January 2003

Completion Date:

January 2005

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Midwest Cancer Research Group, Inc.Skokie, Illinois  60077
Dana Farber Cancer InstituteBoston, Massachusetts  02115
M.D. Anderson Cancer CenterHouston, Texas  77030
Santa Monica Hematology/Oncology ConsultantsSanta Monica, California  90404