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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center AstraZeneca Amgen |
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Information provided by: | UNC Lineberger Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00280787 |
Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation. The standard treatment for this disease is a combination of chemotherapy and radiation therapy; however, the best way to combine these treatments is not known. This study will examine if the combination of chemotherapy and radiotherapy has an increased effect on slowing tumor growth with the addition of a drug called ZD1839.
In this study, chemotherapy will be given initially (induction therapy) to try to control the spread of the cancer. Then radiation and chemotherapy will be given together. Receiving chemotherapy at the same time as radiation treatments can enhance the effect of the radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on cancer cells, ZD1839 has shown an additive effect when used in combination with radiation. ZD1839 has also been shown to slow or stop growth in tumors.
The purpose of this study is to determine the side effects and effectiveness of using ZD1839 when used with radiation in this treatment regimen (induction chemotherapy followed by combination chemotherapy, ZD1839, and radiation therapy).
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: Paclitaxel, Carboplatin, CPT-11, ZD1839 Procedure: Radiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | LCCC 0215: Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim Support Followed by Conformal Radiotherapy and Paclitaxel/Carboplatin/ZD1839 in Locally Advanced Unresectable Stage IIIA/B Non-Small Cell Carcinoma of the Lung |
Estimated Enrollment: | 26 |
Study Start Date: | November 2003 |
Lung cancer remains the leading cause of cancer-related mortality in the United States. In 2002, approximately 170,000 new cases of lung cancer will be diagnosed, and approximately 160,000 deaths will occur. Eighty percent of cases of lung cancer are of the non-small cell type, and 30 to 35% will be Stage IIIA/B and are considered potentially curable. The standard of care in the United States for those patients with unresectable Stage IIIA/B and a good performance status (PS) is a combination of systemic chemotherapy and thoracic radiation therapy (TRT). What is not clear in the management of these patients is the optimal strategy to employ in the combined-modality approach, as well as the optimal chemotherapy and radiation therapy dose and schedule.
Induction and Concurrent Chemoradiation Therapy for Stage IIIA/B NSCLC The use of combined modality has become the standard of care in unresectable Stage IIIA/B non-small cell lung cancer (NSCLC). In the curative approach to this disease, both local control and eradication of occult micrometastatic disease must be achieved. Combined-modality trials employing induction chemotherapy have suggested a reduction in the rate of metastatic disease, suggesting that effectively delivered chemotherapy can eradicate occult micrometastatic disease. All of the trials cited have shown improved survival for the combined-modality arm. Combined-modality trials employing concurrent chemoradiation have suggested improved loco-regional control resulting in improved survival. These data suggest that both induction and concurrent treatment may be important and may exert their benefit in different manners: induction therapy with effective chemotherapy reduces the rate of overt metastatic disease, while concurrent treatment improves local control by enhancing the local effect of TRT. Four trials to date have been published addressing sequential versus concurrent therapy. In these trials, concurrent treatment yielded improved survival over the sequential approach. The value of either induction or consolidation therapy in addition to concurrent chemotherapy is currently being addressed in randomized Phase III trials.
The study will evaluate the incorporation of ZD1839 with concurrent CP and TCRT to a dose of 74 Gy following 2 cycles of induction CIP. The primary objective will be to define the toxicity profile of this approach. With amendment 2, patients will no longer receive maintenance ZD1839. Given the data generated on LCCC 9603 and 2001, this “hybrid” platform of induction CIP followed by concurrent TCRT (74 Gy) and CP seems appropriate for incorporation of ZD1839 because of the general tolerance of this therapy in good PS, unresectable, Stage III NSCLC subjects. Given that esophagitis is the primary toxicity seen with this approach, stopping rules will be in place for excessive esophageal toxicity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject with disease designated T3, N0-N1 based on mediastinal invasion or proximity to the carina.
Subjects with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed within the radiation port.
Subjects with laboratory values as follows:
Absolute granulocyte count: ≥1,500/µL Platelets: ≥100,000/µL Total bilirubin: ≤1.5 x institutional upper normal limit Serum creatinine: <1.6 mg/dL or Creatinine clearance:>40 mL/min
AST and ALT: ≤2.5 x institutional upper normal limit FEV 1 >800 cc
Exclusion Criteria:
Subjects with a history of other cancers except in situ carcinoma of the cervix or breast, inactive nonmelanomatous skin cancer, or other cancer, unless the subject has been free of disease for > 5 years.
Also, exceptions can be made by the PI for a subject with a malignancy for which the prognosis is substantially better than the subject’s prognosis for NSCLC.
United States, North Carolina | |
University of North Carolina Lineberger Comprehensive Cancer Center | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | David Morris, MD | The University of North Carolina, Chapel Hill |
Study ID Numbers: | LCCC 0215 |
Study First Received: | January 19, 2006 |
Last Updated: | April 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00280787 |
Health Authority: | United States: Institutional Review Board |
unresectable induction radiotherapy ZD1839 |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases |
Irinotecan Carboplatin Gefitinib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |