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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study of Calcitriol and Carboplatin in Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	PCI-97-004 PCI-IRB-970532, NCI-G00-1885, NCT00008086

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may help solid tumor cells develop into normal cells. Combining calcitriol with chemotherapy may kill more tumor cells.

Phase I trial to study the effectiveness of calcitriol combined with carboplatin in treating patients who have advanced solid tumors.

Eligibility:

• At least 18 years old
• At least 4 weeks since biological therapy, chemotherapy, or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be assigned to one of two groups. Patients in group one will receive an infusion of carboplatin on day 1. During the first course of treatment, patients will also receive calcitriol by injection or by mouth on days 2-4. In subsequent courses, patients will receive calcitriol on days 1-3 and carboplatin on day 3. Patients in group two will receive calcitriol by injection or by mouth on days 1-3 and an infusion of carboplatin on day 3 during the first, third, and subsequent courses. During the second course of treatment, patients will receive carboplatin on day 1 and calcitriol on days 2-4. Treatment in both groups may be repeated every 4 weeks for as long as benefit is shown.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

UPMC Cancer Centers

Ramesh Ramanathan, MD, Protocol chair		Ph: 412-648-6507

Registry Information
Official Title		A Phase I Trial of Subcutaneous And/Or Oral Calcitriol [(1,25-COH)2D3] and Carboplatin in Advanced Solid Tumors
Trial Start Date		1996-01-23
Registered in ClinicalTrials.gov		NCT00008086
Date Submitted to PDQ		2000-11-14
Information Last Verified		2002-10-01
NCI Grant/Contract Number		CA47904

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