Status:
COMPLETED
Bortezomib and Pemetrexed Disodium in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed disodium may kill mo...
Detailed Description
OBJECTIVES: Primary * Determine the safety, including dose-limiting toxicities, and feasibility of combining bortezomib with pemetrexed disodium in patients with advanced non-small cell lung cancer ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Cytologically or histologically confirmed diagnosis of 1 of the following:
- Advanced solid tumor that progressed after standard therapy or for which no effective curative therapy exists (phase I)
- Stage IIIB (pleural effusion) or IV non-small cell lung cancer (NSCLC) (phase II)
- Disease must have progressed or recurred after 1 platinum-based therapy regimen
- NSCLC that has progressed or recurred after first-line therapy for stage IIIA or IIIB disease allowed
- Measurable disease
- Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiotherapy
- Evaluable disease (bone metastases, pleural fluid, ascites) allowed (phase I)
- No symptomatic brain metastasis or disease requiring steroids and anticonvulsants
- Asymptomatic, previously treated (surgical resection or radiotherapy) brain metastases allowed provided patient is neurologically stable and has been off steroids and anticonvulsants for ≥ 4 weeks
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2 (phase I) or 0-1 (phase II)
- Life expectancy ≥ 3 months
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
- Bilirubin normal
- AST ≤ 2.5 times upper limit of normal
- Granulocyte count ≥ 1,500/mm³
- Platelet count of ≥ 100,000/mm³
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No pre-existing neuropathy ≥ grade 2
- No other prior malignancy except for the following (phase II):
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer currently in complete remission
- Any other cancer from which the patient has been disease free for \> 5 years
- No hypersensitivity to bortezomib, boron, or mannitol
- No cardiovascular complications, including any of the following:
- Myocardial infarction within the past 6 months
- New York Heart Association class III-IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Electrocardiographic (ECG) evidence of acute ischemia or active conduction system abnormalities
- Any ECG abnormality at screening must be documented as not medically relevant
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior bortezomib or pemetrexed disodium
- Any number of prior chemotherapy regimens allowed (phase I)
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C) and recovered
- More than 2 weeks since prior radiotherapy and recovered
- No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2 days prior and 2 days after (5 days pre and post for long-acting NSAIDs) administration of pemetrexed disodium
- No concurrent anticonvulsants that are metabolized by the cytochrome P450 pathway
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00389805
Start Date
March 1 2005
End Date
June 1 2007
Last Update
October 31 2018
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817