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Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant 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 Doxil in Platinum Refractory or Resistant Ovarian Cancer

Inclusion Criteria


Inclusion Criteria

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

- Recurrent epithelial ovarian cancer or persistent disease following primary treatment

- At least one, but no more than four, prior platinum-containing chemotherapy regimens

- At least one prior taxane-containing regimen

Exclusion Criteria

- A 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
the patient has been disease-free for 2 years

- Known leptomeningeal metastases or carcinomatous meningitis

- Have received prior Doxil or other liposomal doxorubicin

- 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:

TLK286.2011

NCT ID:

NCT00052065

Start Date:

February 2003

Completion Date:

March 2006

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

M.D. Anderson Cancer CenterHouston, Texas  77030