Paricalcitol and Gemcitabine in Treating Patients With Advanced Cancer

NCT00217477 | Completed Phase 1 DMC

• 1 other identifier: CDR0000441212
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Paricalcitol may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving paricalcitol together with gemcitabine may be an effective treatment for cancer. PURPOSE: This phase I trial is studying the side effects and best dose of paricalcitol when given together with gemcitabine in treating patients with advanced cancer.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) of i. v. pancalcitol given weekly, in combination with fixed dose rate infusion of i. v.gemcitabine given weekly in patients with advanced malignancies.

  4 weeks

Secondary Outcomes (6)

• To assess toxicity.

  8 week intervals

• To determine the effects of paricalcitol on the pharmacokinetics of gemcitabine.

  Days 1 & 8, cycle 1

• To determine the effects of pariclcitol on cytidine deaminase in PBM

  Days 1 & 8, cycle 1

• To determine the effects of paricalcitol on dFdCTP in PBM

  Days 1 & 8, cycle 1

• To determine the pharmacokinetics of paricalcitol when given with gemcitabine

  Day 7, cycle 1

Study Arms (1)

Paricalcitol IV in combination with Gemcitabine IV

EXPERIMENTAL

Patients receive gemcitabine hydrochloride IV over 80 minutes on days 1, 8, and 15 and paricalcitol IV over 15 minutes on days 7 and 14 in course 1. Beginning in course 2, patients receive paricalcitol IV over 15 minutes on days 1, 8, and 15 and gemcitabine hydrochloride IV over 80 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: gemcitabine hydrochloride; Drug: paricalcitol

Interventions

gemcitabine hydrochloride DRUG

Given IV

Paricalcitol IV in combination with Gemcitabine IV

paricalcitol DRUG

Given IV

Paricalcitol IV in combination with Gemcitabine IV

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of advanced malignancy * Metastatic or unresectable disease * Standard curative or palliative measures do not exist or are no longer effective * No known brain metastases * Patients with previously treated brain metastases are eligible provided they have recovered from prior treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 3.0 times upper limit of normal Renal * Creatinine ≤ 2.0 mg/dL * Corrected calcium ≤ 10.5 mg/dL * Prior single confirmed urolithiasis allowed provided patient is free of stone formation for ≥ 5 years * No calculi in the urinary tract on kidney ultrasound biopsy or other imaging studies Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior chemotherapy and recovered Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * Curative therapy for a condition associated with the risk of renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patients have been free of stone formation for ≥ 5 years * No concurrent digoxin * No other concurrent investigational agents

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Abbott: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Interventions

Gemcitabine; paricalcitol

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Renuka Iyer, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2004
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2014
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

US (1)