Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
UPMC Cancer Centers National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00009802 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with paclitaxel in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: calcitriol Drug: paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors |
Study Start Date: | June 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of calcitriol.
During course 1, patients receive oral calcitriol daily on days 1-3 of weeks 1-6 and paclitaxel IV over 1 hour on day 1 of week 1 and day 3 of weeks 2-6.
During course 2 and subsequent courses, patients receive oral calcitriol daily on days 1-3 and paclitaxel IV over 1 hour on day 3 of weeks 1-6. Treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose giving an estimated probability of dose-limiting toxicity of no more than 0.30.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15213-3489 |
Study Chair: | Ramesh K. Ramanathan, MD | UPMC Cancer Centers |
Study ID Numbers: | CDR0000068411, PCI-98019, PCI-IRB-980542, NCI-G00-1901 |
Study First Received: | February 2, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00009802 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Calcium, Dietary Paclitaxel Vitamins Tubulin Modulators Vasoconstrictor Agents Bone Density Conservation Agents |
Trace Elements Antimitotic Agents Cardiovascular Agents Micronutrients Antineoplastic Agents, Phytogenic Calcitriol |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Mitosis Modulators Physiological Effects of Drugs Calcium Channel Agonists Bone Density Conservation Agents Antimitotic Agents Cardiovascular Agents Pharmacologic Actions |
Calcitriol Membrane Transport Modulators Paclitaxel Therapeutic Uses Vitamins Tubulin Modulators Vasoconstrictor Agents Micronutrients Antineoplastic Agents, Phytogenic |