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Home > "B" Clinical Trials Conditions > Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer  Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,Malignant Pleural Effusion,stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer
Status: Recruiting
Sponsor(s): California Cancer Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with gemcitabine and carboplatin in treating patients who have advanced or recurrentnon-small cell lung cancer.
Details: OBJECTIVES: - Determine the safety and feasibility of combining bortezomib with gemcitabine and carboplatin in patients with advanced or recurrent non-small cell lung cancer. - Determine the maximum tolerated dose of bortezomib administered in combination with gemcitabine and carboplatin in these patients. - Correlate results from laboratory studies on patient tissue and serum specimens with potential predictors of response in patients treated with this regimen. - Determine, preliminarily, the response of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of bortezomib. Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, followed 1 hour later by bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a clinical or radiographic response may continue receiving bortezomib beyond 6 courses. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 10 additional patients with chemotherapy-naive disease receive treatment as above with the MTD of bortezomib. Patients are followed for survival. PROJECTED ACCRUAL: A total of 25-34 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than than 1.5 mg/dL - AST no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 50 mL/min 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 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 PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent routine filgrastim (G-CSF) Chemotherapy - 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 Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery - See Disease Characteristics Other - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AngelaDavies, Study Chair, University of California Davis Cancer Center
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Stephen Shibata 626-359-8111 ext. 63087
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Angela Davies 916-734-3771
Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez, California, 94553
United States
Recruiting David Gandara 925-372-2064
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Additional Information:
Study ID Numbers: CDR0000258189; CHNMC-PHI-40,CCC-PHI-40,NCI-5856
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052338
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
3. Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
5. Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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