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



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

For Condition: Ovarian Neoplasms
Status: Recruiting
Sponsor(s): Telik ,
Synopsis: This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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
Total Enrollment: 28

Location and Contact Information:

M.D. Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Mercedes  Bolanos-Clark 713-745-1088


Additional Information:
Study ID Numbers:
  TLK286.2011; 
Study Start Date: January 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052065

Other Ovarian Neoplasms Studies:
1. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies

2. Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma

3. Phase 3 Study of TLK286 vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

4. Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer

5. Phase 1-2a Study of TLK286 in Combination with Doxil in Platinum Refractory or Resistant Ovarian Cancer

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

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