Calcitriol Plus Paclitaxel in Treating Patients With Advanced Solid Tumors
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unspecified Adult Solid Tumor, Protocol Specific
Intervention: calcitriol (Dietary Supplement); paclitaxel (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Ramesh K. Ramanathan, MD, Study Chair, Affiliation: University of Pittsburgh
Summary
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.
Clinical Details
Official title: A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors
Study design: Primary Purpose: Treatment
Detailed description:
OBJECTIVES:
- Determine the toxic effects and maximum tolerated dose of calcitriol when combined with
paclitaxel in patients with advanced solid tumors.
- Determine the effect of administration of calcitriol on the pharmacokinetics of
paclitaxel in these patients.
- Determine the effect of administration of paclitaxel on the pharmacokinetics of
calcitriol in these patients.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically proven advanced cancer not curable by standard therapies
- Brain metastases allowed following definitive radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1. 5 mg/dL
- SGOT no greater than 4 times normal
Renal:
- Creatinine no greater than 2. 0 mg/dL
- Calcium no greater than 10. 5 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception for at least 1 week
before, during, and for at least 2 weeks after study
- No active infection or serious concurrent condition
- No symptomatic peripheral neuropathy greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior regional or systemic biologic therapy
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy
Surgery:
- Not specified
Locations and Contacts
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213-3489, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1998
Last updated: December 18, 2013
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