Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effect on the body of combining oxaliplatin with bortezomib in treating patients who have metastatic or unresectable cancer. Drugs used in chemotherapy such as oxaliplatin use different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. Combining oxaliplatin with bortezomib may kill more cancer cells

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed malignancy for which standard curative or palliative measures do not exist or are no longer effective

• Metastatic or unresectable disease

• No known brain metastases

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100

• More than 6 months

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin normal

• AST and ALT no greater than 5 times upper limit of normal

• Creatinine no greater than 1.5 mg/dL

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of allergic reactions attributed to compounds of similar chemical or biological composition to any platinum or other study agents

• No pre-existing peripheral neuropathy

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• No other concurrent uncontrolled illness

• Prior thalidomide allowed provided patient has no clinical neuropathy

• Prior platinum or antitubulin agents allowed provided patient has no clinical neuropathy

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered

• More than 3 weeks since prior radiotherapy and recovered

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational or commercial agents or therapies for the malignancy