A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Ramesh K. Ramanathan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Federal Government
Study ID:
CDR0000068411
NCT ID:
NCT00009802
Start Date:
June 1998
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
