Calcitriol Plus Paclitaxel in Treating Patients With Advanced Solid Tumors

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00009802

Enrollment

Registered

2003-06-06

Start date

1998-06-30

Completion date

2005-06-30

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTcalcitriol

DRUGpaclitaxel

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026