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A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 InstitutePittsburgh, Pennsylvania  15213