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Trial Name:

GOG 0209

Intro: Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF versus Carboplatin/Paclitaxel in Patients with Stage III and IV or Recurrent Endometrial Cancer
Condition:
Description: This study will determine if the combination of carboplatin and paclitaxel chemotherapy is therapeutically equivalent to the combination of doxorubicin, cisplatin and paclitaxel chemotherapy with regards to survival. Patients are randomized to receive either doxorubicin, cisplatin, paclitaxel and G-CSF or carboplatin and paclitaxel. Cycles are repeated every 21 days.
Criteria:
  1. Patients must have primary Stage III or IV or recurrent endometrial carcinoma whose potential for cure by radiation therapy or surgery alone or in combination is very poor. May not have received prior chemotherapy. At least 4 weeks should have elapsed since completion of radiation therapy
  2. Must have measurable disease
  3. Must have adequate bone marrow, liver and heart function
  4. Must have a GOG performance status 0-2
  5. Must not have a concomitant malignancy with the exception of non-melanoma skin cancer. Patients with a prior malignancy who have been disease free for < 5 years or who received prior chemotherapy for that malignancy are not eligible
  6. Patients must not have a concomitant medical illness such as serious uncontrolled infection, uncontrolled angina or serious peripheral neuropathy. Patients with a third degree or complete heart block are not eligible unless a pacemaker is in place
  7. Must not be sensitive to E. Coli-derived drug preparations.
Contact: For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422

Participant Confidentiality:

All information regarding participation in Clinical Trials is treated with the utmost confidentiality. University Hospitals Case Medical Center and the Division of Clinical Research recognize and respect the confidentiality of this information. Access to information related to clinical trials and their participants is restricted to authorized clinical trials personnel only.

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