A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase
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| ClinicalTrials.gov Identifier: NCT00528281 |
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Recruitment Status :
Completed
First Posted : September 12, 2007
Last Update Posted : November 17, 2017
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This phase II study is a single-arm, two-stage, multicentre study to determine the clinical activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. There will be a short safety run in portion of the study to determine the optimal treatment regimen (OTR) for the combination, since these two drugs have not previously been used together.
Approximately 27 patients will be enrolled into the first stage of the study and if sufficient responses are seen an additional 27 patients will be enrolled into the second stage giving an overall evaluable patient number of 54. Patients will be treated with pemetrexed plus lapatinib at the determined OTR to disease progression, death or withdrawal from the study treatment for any reason.
Safety and efficacy assessments will be performed on all patients at 6-week intervals, as well as at the end of treatment. Patients withdrawn from study treatment with stable disease will be assessed every 6 weeks until progression. Thereafter, patients will be followed for survival at approximately 12-week intervals until death or to a maximum of 5 years after last patient is enrolled, whichever comes first.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer, Non-Small Cell | Drug: Lapatinib Drug: Pemetrexed | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 18 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Single-arm, Two-stage Phase II Study of Lapatinib and Pemetrexed in the Second Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer |
| Actual Study Start Date : | September 20, 2007 |
| Actual Primary Completion Date : | May 27, 2009 |
| Actual Study Completion Date : | May 27, 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lapatinib + pemetrexed
This is a single-arm, two-stage, multicenter Phase II study to determine the clinical activity of pemetrexed with lapatinib.
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Drug: Lapatinib
Lapatinib was administered once daily orally. Patients will begin treatment at Dose Level 0, using a lower dose of pemetrexed, 400mg (approved dose is 500mg). Absent a DLT or need for treatment delay in cycle 1, Dose level 0 or 1, patients may be dose escalated to dose level 1 or 2, respectively in cycle 2. Drug: Pemetrexed Pemetrexed is administered intravenously on a 21 day schedule. Two dose levels are used in the dose escalation: 400 and 500 mg. |
- OTR of the combination of lapatinib and pemetrexed
- anti-tumour activity of lapatinib in terms of overall response rate
- anti-tumour activity of lapatinib in terms of duration of response, time to response, time to progression, overall survival
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
- Signed informed consent;
- Patients must be 18 years old;
- Subjects must have stage IIIB or IV NSCLC .
- Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of 12 weeks;
- Have adequate organ function baseline laboratory values for inclusion;
EXCLUSION CRITERIA:
- History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
- Known history of or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for = 3 months prior to study enrollment.
- Peripheral neuropathy of grade 3 or higher;
- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
- Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU prodrug.
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): NCT00528281
| Germany | |
| GSK Investigational Site | |
| Heidelberg, Baden-Wuerttemberg, Germany, 69126 | |
| GSK Investigational Site | |
| Grosshansdorf, Schleswig-Holstein, Germany, 22927 | |
| Italy | |
| GSK Investigational Site | |
| Orbassano (TO), Piemonte, Italy, 10043 | |
| Poland | |
| GSK Investigational Site | |
| Poznan, Poland, 60-569 | |
| United Kingdom | |
| GSK Investigational Site | |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00528281 History of Changes |
| Other Study ID Numbers: |
EGF109462 |
| First Posted: | September 12, 2007 Key Record Dates |
| Last Update Posted: | November 17, 2017 |
| Last Verified: | November 2017 |
Keywords provided by GlaxoSmithKline:
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Non Small Cell Lung Cancer (NSCLC) Pemetrexed, Lapatinib (GW572016), |
Additional relevant MeSH terms:
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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 Lapatinib Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |