Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase I Study Of PS-341 In Combination With Gemcitabine And Carbloplatin In Selected Stage IIIB Or IV Non-Small Cell Lung Cancer
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
Status | Completed |
Enrollment | 34 |
Est. completion date | |
Est. primary completion date | May 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | City of Hope | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicities at each dose level, graded using the CTC version 2.0 | Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, (by NCI Common Toxicity Criteria and nadir or maximum values for the laboratory measures, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and course. | 18 weeks | Yes |
Secondary | Response rate, assessed by standard RECIST criteria | Summarized by exact binomial confidence intervals. | Up to 2 years | No |
Secondary | Survival | Summarized with Kaplan-Meier plots. | From registration to time of death due to any cause, assessed up to 2 years | No |
Secondary | Time to failure | Summarized with Kaplan-Meier plots. | Up to 2 years | No |
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