Calcitriol Plus Paclitaxel in Treating Patients With Advanced Solid Tumors

NCT00009802 | Completed Phase 1

• 4 other identifiers: 98-019CDR0000068411PCI-IRB-980542NCI-G00-1901
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

calcitriol DIETARY_SUPPLEMENT

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

MeSH Terms

Interventions

Calcitriol; Paclitaxel

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ramesh K. Ramanathan, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: June 6, 2003
• Study Start: June 1, 1998
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

US (1)