Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

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

Summary

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and bortezomib may kill more tumor cells

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

Details

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

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer

• Selected stage IIIB (malignant pleural effusion) or stage IV disease

• Recurrent disease after first-line therapy allowed

• Patients who received prior platinum-based chemotherapy must have no disease progression during or within 3 months after completion of therapy

• Patients who are enrolled at the maximum tolerated dose must have chemotherapy-naïve disease

• Evaluable disease

• Asymptomatic brain metastases allowed if treated with surgical resection or radiotherapy, neurologically stable, and off steroids for at least 4 weeks

• Performance status - Karnofsky 60-100%

• More than 3 months

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

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

• Bilirubin no greater than 1.5 mg/dL

• AST no greater than 2.5 times upper limit of normal

• Creatinine normal

• Creatinine clearance at least 50 mL/min

• 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 peripheral neuropathy grade 2 or greater

• No prior allergic reactions to compounds of similar chemical or biological composition to bortezomib or other agents used in this study

• No concurrent ongoing or active infection

• No other concurrent uncontrolled illness

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

• No concurrent routine filgrastim (G-CSF)

• See Disease Characteristics

• No more than 1 prior chemotherapy regimen

• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

• No prior gemcitabine

• See Disease Characteristics

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

• See Disease Characteristics

• More than 30 days since prior investigational drugs

• No prior bortezomib

• No concurrent anticonvulsant therapy

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational or commercial agents or therapies with intent to treat malignancy