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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00093392 |
RATIONALE: ZD6474 may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining ZD6474 with carboplatin and paclitaxel may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with ZD6474 works compared to carboplatin and paclitaxel alone in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: paclitaxel Drug: vandetanib Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control |
Official Title: | A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 Alone or in Combinaiton With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 220 |
Study Start Date: | May 2004 |
Arms | Assigned Interventions |
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Arm I (part 2 randomized phase): Experimental
Patients receive oral ZD6474 once daily at the appropriate and tolerable dose determined in part 1.
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Drug: vandetanib
Given orally
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Arm II (part 2 randomized phase): Experimental
Patients receive oral ZD6474 once daily on days 1-21 and paclitaxel and carboplatin as in part 1. Treatment repeats every 21 days for 6 courses. Patients achieving a PR, CR, or SD after 6 courses of therapy receive oral ZD6474 alone once daily. |
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: vandetanib
Given orally
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Arm III (part 2 randomized phase): Active Comparator
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in part 1. Treatment repeats every 21 days for 6 courses. Patients achieving a PR, CR, or SD after 6 courses of therapy receive oral placebo alone once daily. |
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Other: placebo
Given orally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
Measurable disease
No brain metastasis or spinal cord compression unless both of the following are true:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No prior radiotherapy
Surgery
Other
More than 2 weeks since prior and no concurrent administration of the following:
Potent inhibitors of CYP3A4, including any of the following:
Potent inducers of CYP3A4, including any of the following:
Therapeutic doses of warfarin for an INR ≥ 2
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-7187 | |
Contact: Fairooz F. Kabbinavar, MD 310-206-3921 |
Principal Investigator: | Fairooz F. Kabbinavar, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000386240, UCLA-0405022-01, ZENECA-D4200C00007, ZENECA-D4200C007A |
Study First Received: | October 6, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00093392 History of Changes |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Carboplatin Antimitotic Agents Recurrence Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |