Nelfinavir, Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

NCT00589056 | Completed Phase 1 Results DMC

• 3 other identifiers: UPCC 04507IRB-806285CDR0000582319
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting Toxicity

  Any grade III or higher toxicity during chemoradiation, per CTCAE

  90 days

• Maximum Tolerated Dose of Nelfinavir

  As determined by dose escalation rules

  90 days

Secondary Outcomes (1)

• Clinical Response of Tumor

  90 days

Study Arms (1)

Single arm

EXPERIMENTAL

Nelfinavir

Drug: cisplatin; Drug: etoposide; Drug: nelfinavir mesylate; Genetic: protein expression analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: biopsy; Radiation: radiation therapy

Interventions

cisplatin DRUG

Single arm

etoposide DRUG

Single arm

nelfinavir mesylate DRUG

Single arm

protein expression analysis GENETIC

Single arm

immunohistochemistry staining method OTHER

Single arm

laboratory biomarker analysis OTHER

Single arm

biopsy PROCEDURE

Single arm

radiation therapy RADIATION

Single arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Publications (1)

• Rengan R, Mick R, Pryma DA, Lin LL, Christodouleas J, Plastaras JP, Simone CB 2nd, Gupta AK, Evans TL, Stevenson JP, Langer CJ, Kucharczuk J, Friedberg J, Lam S, Patsch D, Hahn SM, Maity A. Clinical Outcomes of the HIV Protease Inhibitor Nelfinavir With Concurrent Chemoradiotherapy for Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer: A Phase 1/2 Trial. JAMA Oncol. 2019 Oct 1;5(10):1464-1472. doi: 10.1001/jamaoncol.2019.2095.

  PMID: 31436839 DERIVED

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Etoposide; Nelfinavir; Immunohistochemistry; Biopsy; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Therapeutics

Results Point of Contact

• Title: Ramesh Rengan, M.D., Ph.D.
• Organization: University of Pennsylvania

Rengan@xrt.upenn.edu

(215) 662-2428

Study Officials

• Amit Maity

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2007
• First Posted: January 9, 2008
• Study Start: June 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Locations

US (1)