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Contact Information

General Phone Number
888-844-8447
216-844-8447
Mailing Address
11100 Euclid Avenue
Cleveland, OH 44106
Clinical Trials

Trial Name:

CASE 5Y03
Intro: A Double-Blind Randomized Trial of Pyridoxine versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)
Condition:
Description: This study will compare the efficacy of pyridoxine versus placebo in the prevention of PPE/HFS in patients treated with Doxil with recurrent ovarian cancer or metastatic breast cancer. Patients will be randomized to receive either Doxil plus Pyridoxine every 4 weeks or Doxil plus placebo every 4 weeks until disease progression or unacceptable toxicity.
Criteria:
  1. Patients must be treated for recurrent ovarian cancer, metastatic breast cancer or advanced endometrial cancer
  2. Patients must be initiating Doxil chemotherapy. Patients may receive concurrent chemotherapy so long as the additional chemotherapeutic agent does not cause PPE/HFS
  3. Any hormonal therapy directed at the malignant tumor, must be discontinued at least one week prior to registration. Any other prior therapy directed at the malignant tumor, including radiotherapy, biological and immunologic agents, must be discontinued at least 3 weeks prior to registration
  4. Patients who have had prior therapy with Doxil are not eligible
  5. Patients must have normal bone marrow, liver, kidney and heart function.
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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