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

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ClinicalTrials.gov Identifier: NCT00589056
Recruitment Status : Active, not recruiting
First Posted : January 9, 2008
Last Update Posted : September 26, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: etoposide Drug: nelfinavir mesylate Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:



  • To determine the dose-limiting toxicities, maximum tolerated dose, and recommended phase II dose of nelfinavir mesylate when administered in combination with concurrent thoracic radiotherapy, cisplatin, and etoposide in patients with unresectable locally advanced non-small cell lung cancer.


  • To determine the tumor response at 3 months after completion of treatment as measured by RECIST criteria.
  • To assess the inhibition of p-Akt in primary tumor or pathologic lymph nodes and in peripheral blood lymphocytes after 5-10 days of treatment with nelfinavir mesylate.
  • To determine the median overall survival (OS) of patients treated with this regimen.
  • To compare the observed median OS of these patients with the historical median OS of 17 months.

OUTLINE: This is a phase I, dose-escalation study of nelfinavir mesylate followed by a phase II study.

  • Phase I: Patients receive oral nelfinavir mesylate twice daily beginning 1-2 weeks before the initiation of chemoradiotherapy and continuing until the completion of radiotherapy. Patients undergo thoracic radiotherapy once daily 5 days a week for 7-8 weeks. Patients also receive cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and 29-33. After completion of chemoradiotherapy, patients receive two additional courses of cisplatin and etoposide.
  • Phase II: Patients receive nelfinavir mesylate at the maximum tolerated dose determined in phase I and concurrent chemoradiotherapy as in phase I.

Patients undergo blood sample collection periodically for correlative laboratory studies. Patients treated in the phase II portion of the study and those with primary tumors or pathologic lymph nodes easily accessible by core biopsy or mediastinoscopy also undergo tumor tissue biopsies. Blood and tumor tissue samples are analyzed for expression of molecular markers (total Akt and p-Akt ) by immunohistochemistry. The molecular markers are correlated with treatment response.

After completion of study treatment, patients are followed at 3, 6, and 12 months.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Protease Inhibitor, Nelfinavir, Given With Concurrent Thoracic Chemoradiotherapy in Patients With Locally-Advanced Non-Small Cell Lung Cancer
Study Start Date : June 2007
Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nelfinavir
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Dose-limiting toxicity as measured by NCI Common Toxicity Criteria
  2. Maximum tolerated dose and recommended phase II dose of nelfinavir mesylate

Secondary Outcome Measures :
  1. Response at 3 months after completion of treatment as measured by RECIST criteria
  2. Overall survival
  3. Expression of molecular markers (total Akt and p-Akt) in primary tumor or pathologic lymph nodes and in peripheral blood lymphocytes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589056

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Amit Maity Abramson Cancer Center of the University of Pennsylvania
More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00589056     History of Changes
Other Study ID Numbers: CDR0000582319
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents