Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00389805
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00389805
Study Brief:
Protocol Section:
NCT00389805