Phase 2
N=55
Nelfinavir, Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00589056 ↗Enrolled (actual)
55
Serious AEs
38.2%
Results posted
Apr 2020
Primary outcome: Primary: Dose-limiting Toxicity — 0 Dose-limiting toxicities
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); etoposide (Drug); nelfinavir mesylate (Drug); protein expression analysis (Genetic); immunohistochemistry staining method (Other); laboratory biomarker analysis (Other); biopsy (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-limiting Toxicity |
— | — |
| PRIMARY Maximum Tolerated Dose of Nelfinavir |
1250 | — |
| SECONDARY Clinical Response of Tumor |
94 | — |
Summary
RATIONALE: Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Nelfinavir may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir together with radiation therapy, cisplatin, and etoposide may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir when given together with radiation therapy, cisplatin, and etoposide and to see how well they work in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer
- Locally advanced (stage III) disease
- Unresectable disease
- Candidate for concurrent definitive chemotherapy and thoracic radiotherapy, as determined by the treating physician
- No malignant pleural effusion
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- AST or ALT ≤ 2 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- FEV\_1 > 600 cc
- Not pregnant or nursing
- Negative pregnancy test
- No weight loss > 10% within the past 6 months
- No known HIV disease
PRIOR CONCURRENT THERAPY:
- No prior thoracic radiotherapy
- No prior HIV protease inhibitors
- More than 5 years since prior chemotherapy
- At least 3 weeks since prior exploratory thoracotomy
- No concurrent medications that would preclude nelfinavir administration, including any of the following:
- Amiodarone
- Quinidine
- Rifampin
- Dihydroergotamine
- Ergonovine
- Ergotamine
- Methylergonovine
- Hypericum perforatum (St. John's wort)
- Lovastatin
- Simvastatin
- Pimozide
- Midazolam
- Triazolam
Data sourced from ClinicalTrials.gov (NCT00589056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.