NCT01039155

Azacitidine and Oxaliplatin In Treating Patients With Advanced Cancers Relapsed or Refractory to Any Platinum Therapy

A Phase 1 Study of CTEP 5-Azacytidine in Combination With Oxaliplatin in Patients With Advanced Cancers Relapsed or Refractory or Refractory to Any Platinum Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I clinical trial studies the side effects and the best dose of azacitidine and oxaliplatin in treating patients with advanced cancers that do not respond to treatment or have returned after any platinum therapy. Azacitidine is designed to activate (turn on) certain genes in cancer cells whose job is to fight tumors. Oxaliplatin is designed to block the growth and spread of new cancer cells, eventually destroying them, by damaging their deoxyribonucleic acid (DNA). Giving azacitidine with oxaliplatin may kill more cancer cells and may also reverse resistance to platinum-based drugs.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of 5-azacytidine (azacitidine) and oxaliplatin combination regimen in patients with advanced solid tumors or lymphomas relapsed or refractory to any platinum compound. II. To define 5-azacytidine and oxaliplatin pharmacokinetics. SECONDARY OBJECTIVES: I. For patients treated in the expansion phase of this study: (a) to assess copper transport protein (CTR1) score; (b) to assess changes in global DNA methylation; and (c) to measure changes in oxaliplatin levels in tumor biopsies between pretreatment and day 12 of the first cycle of 5-azacytidine plus oxaliplatin therapy. II. To correlate results of the pharmacokinetic studies of 5-azacytidine and oxaliplatin with changes in CTR1, changes in global DNA methylation and changes in oxaliplatin levels in tissue biopsies of patients treated in the expansion phase of this study. OUTLINE: This is a dose-escalation study. Patients receive azacitidine IV over 15-30 minutes on days 1-5 and oxaliplatin IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Conditions

• Adult Solid Neoplasm
• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

Type	Name	Description
DRUG	Azacitidine	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Oxaliplatin	Given IV
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-09-01
• Completion: 2015-07-01
• First posted: 2009-12-24
• Last updated: 2015-10-06

Locations

1 site across 1 country: United States