Pharmacodynamic Separation of Pemetrexed and Erlotinib as Second-line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Recruitment status was: Recruiting
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Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells, and even shrink the tumors in some patients, by blocking some of the enzymes such as epidermal growth factor receptor (EGFR) needed for cell growth and spread. Pemetrexed is a drug that inhibits several key proteins that require folic acid to synthesize DNA. Blocking DNA synthesis in tumor cells has been shown to decrease tumor growth. can block tumor growth in different ways. Giving erlotinib together with pemetrexed at a specific schedule may kill more tumor cells than giving only pemetrexed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and cetuximab and to see how well they work in treating patients with advanced solid tumors or progressive or recurrent stage III or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Non-small Cell Lung Cancer | Drug: Pemetrexed Drug: pemetrexed and erlotinib | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Schedule-Modulated Concomitant Pemetrexed and Erlotinib Versus Single Agent Pemetrexed in Patients With Progressive or Recurrent Non-Small Cell Lung Cancer (NSCLC) |
- Progression-free survival [ Time Frame: 6 months ]
- Objective response rate [ Time Frame: Every 6 weeks while on study ]
- Disease control rate [ Time Frame: 6 months ]
- Safety profile of pemetrexed and erlotinib combination [ Time Frame: Continously ]
- Assessment of molecular markers for biologic effects and predictive response [ Time Frame: while on study ]
| Estimated Enrollment: | 82 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Pemetrexed Monotherapy
|
Drug: Pemetrexed
500 mg/m2 IV over 10 minutes on day 1 every 21 days
|
|
Experimental: B
Pharmacodynamic separation of pemetrexed and erlotinib
|
Drug: pemetrexed and erlotinib
pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days and erlotinib 150 mg PO once daily on days 2-17 every 21 days
|
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed advanced (Stage IIIB with a malignant pleural effusion or Stage IV disease) or recurrent nonsquamous NSCLC.
- Patients must have at least one measurable disease per RECIST criteria
- Patient must have disease progression after one prior chemotherapy and/or targeted therapy other than pemetrexed or anti-EGFR therapy for metastatic disease, or relapse while receiving adjuvant therapy, or within 12 months of completing adjuvant therapy
Exclusion Criteria:
- Patients who have had immunotherapy, hormone, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients with uncontrolled brain metastases should be excluded from this clinical trial because of their poor prognosis.
- Patients with immune deficiency
Contacts and Locations
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): NCT00950365
| Contact: Tianhong Li, MD, PhD | 718-904-2900 | tli@montefiore.org | |
| Contact: Cheryl Baker, APRN | 718-405-8508 | cbaker@montefiore.org |
| United States, Massachusetts | |
| University of Massachusetts | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: Bilal Piperdi, MD 508-856-3702 piperdib@ummhc.org | |
| Principal Investigator: Bilal Piperdi, MD | |
| Sub-Investigator: William V Walsh, MD | |
| United States, New York | |
| Albert Einstein Cancer Center | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Tianhong Li, MD, PhD 718-904-2900 tli@montefiore.org | |
| Contact: Cheryl Baker, APRN 718-405-8508 cbaker@montefiore.org | |
| Principal Investigator: Tianhong Li, MD, PhD | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Rasim Gucalp, MD 718-920-4826 rgucalp@montefiore.org | |
| Contact: Yoko Eng, RN 718-920-2090 yeng@montefiore.org | |
| Sub-Investigator: Rasim Gucalp, MD | |
| Study Chair: | Tianhong Li, MD, PhD | Montefiore Medical Center |
More Information
| Responsible Party: | Tianhong Li, MD, PhD, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00950365 History of Changes |
| Other Study ID Numbers: |
Pemetrexed/Erlotinib |
| First Submitted: | July 30, 2009 |
| First Posted: | July 31, 2009 |
| Last Update Posted: | July 31, 2009 |
| Last Verified: | July 2009 |
Keywords provided by Montefiore Medical Center:
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer progressive or recurrent stage III or stage IV non-small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |