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Sponsored by: |
National Cancer Centre, Singapore |
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Information provided by: | National Cancer Centre, Singapore |
ClinicalTrials.gov Identifier: | NCT00702182 |
The purpose of this study is to define the schedule and dose of oral navelbine to be used with erlotinib in non-small cell lung cancer
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Vinorelbine Drug: Erlotinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | Phase 1 Study of Oral Vinorelbine in Combination With Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Using Two Different Schedules |
Estimated Enrollment: | 78 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Conventional Schedule Vinorelbine and Erlotinib
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Drug: Vinorelbine
Conventional Schedule Oral Vinorelbine on day 1 and day 8 of a 21 day schedule
Drug: Erlotinib
Daily Erlotinib
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2: Experimental
Metronomic Schedule Vinorelbine and Erlotinib
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Drug: Vinorelbine
Metronomic Schedule Oral Vinorelbine 3 times a week
Drug: Erlotinib
Daily Erlotinib
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Additive or supraadditive activity of an EGFR TK-I with vinorelbine has been demonstrated in-vitro. Clinical synergism has also been described between gefitinib and vinorelbine in NSCLC. The use of cytotoxics in a metronomic schedule has not been well investigated in the clinical setting despite emerging pre-clinical data.
Using an established oral cytotoxic such as oral vinorelbine in a metronomic dose-schedule is attractive due to the oral route of administration. Preclinical studies have shown that by using cytotoxics in a low-dose protracted manner, endothelial cells are preferentially affected via inhibition of proliferation and induction of apoptosis. In addition to this anti-angiogenic mechanism, an anti-vasculogenic process may also be involved that acts by reducing circulating endothelial progenitor mobilization and viability. Moreover, it has also been shown that tumours that were selected for high levels of acquired resistance to cytotoxics can be induced to respond by using metronomic doses of chemotherapy.
Continuous administration of metronomic oral vinorelbine, given three times a week, has been reported as feasible and well tolerated at doses up to 180 mg total dose per week. Early results showed activity against refractory solid tumors such as renal cancer, NSCLC, ovarian cancer, prostate cancer, unknown primary and Kaposi sarcoma.
This phase I study combines erlotinib and oral vinorelbine on two different schedules. The conventional schedule vinorelbine (CSV) aims to determine the MTD of conventional schedule of oral vinorelbine given on days 1 and 8 every 21 days plus daily erlotinib and the metronomic schedule vinorelbine (MSV) aims to determine the optimal metronomic dose of vinorelbine given 3 times a week plus daily erlotinib.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Contact: Wan-Teck Lim, MD | 65-6436-8200 | dmolwt@nccs.com.sg |
Contact: Eng-Huat Tan, MD | 65-6436-8171 | dmoteh@nccs.com.sg |
Singapore | |
National Cancer Center Singapore | Recruiting |
Singapore, Singapore, 169610 |
Principal Investigator: | Wan-Teck Lim, MD | National Cancer Center Singapore |
Responsible Party: | National Cancer Center Singapore ( Wan-Teck Darren Lim ) |
Study ID Numbers: | EPCTG-VEP1 |
Study First Received: | June 19, 2008 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00702182 History of Changes |
Health Authority: | Singapore: Health Sciences Authority |
Lung Cancer Vinorelbine Erlotinib Phase 1 |
Erlotinib Thoracic Neoplasms Vinorelbine Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Vinorelbine Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |