Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Cancer Institute (NCI) Abraxis BioScience Inc. UNC Lineberger Comprehensive Cancer Center |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00454324 |
This is a phase II trial of abraxane and carboplatin in extensive stage small cell lung cancer to examine overall response rate, time to progressive disease, survival time, and assessment of toxicity profile for Carboplatin and Abraxane.
Condition | Intervention | Phase |
---|---|---|
Small Cell Lung Cancer |
Drug: Abraxane and Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer |
Estimated Enrollment: | 42 |
Patients are being asked to be in this study because they have extensive disease small cell lung cancer. All eligible participants who agree to be in the study will receive both abraxane and carboplatin. The researchers want to evaluate the activity and safety of the combination of abraxane and carboplatin, and if this combination can help people with extensive disease small cell lung cancer. Carboplatin is a chemotherapy drug that has been approved by the Food and Drug Administration (FDA) to treat ovarian cancer. It is in a class of drugs known as platinum-containing compounds. It slows or stops the growth of cancer cells in your body. Carboplatin is not approved by the FDA for use in the treatment of small-cell lung cancer, either alone or combined with other anti-cancer drugs. However, carboplatin given with paclitaxel is a standard or active treatment in patients with small cell lung cancer, non-small cell lung cancer, breast cancer, and ovarian cancer. Abraxane is a chemotherapy drug that was approved by the FDA to treat metastatic breast cancer after other chemotherapy has already been tried. Abraxane is a new preparation of the active ingredient in the chemotherapy drug, paclitaxel. In a study done in breast cancer patients, Abraxane was compared to paclitaxel. Abraxane has been shown to be more effective than paclitaxelin tumor response and tumor progression, in addition to having fewer side effects than paclitaxel. Abraxane was shown to cause less damage to a person's white blood cells (the cells that fight infection) and cause fewer allergic reactions; however, more patients developed numbness of their hands and feet.
Carboplatin and Abraxane are intravenous (IV) medications. Patients will begin treatment with 2 cycles (1 cycle = 21 days) of abraxane and carboplating. Then there will be a disease assessment at cycles 2 and 4. Patients with stable disease, partial response, or complete response will get additional cycles. Patients with progressive disease no will be taken off the study treatment. A maximum of 6 cycles will be given.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(*)ES-SCLC defined as metastases outside the chest, pulmonary metastases, or contralateral metastases (supraclavicular or hilar) nodes that could not be included with a reasonable single radiation port. Patients with malignant pleural effusions are considered extensive stage.
Exclusion Criteria:
Contact: Maureen Tynan, RN, OCN | 919-966-4432 | Tynanm@med.unc.edu |
Contact: Tammy Allred, RN, OCN | 919-966-4432 | Tammy_Allred@med.unc.edu |
United States, North Carolina | |
University of North Carolina Lineberger Comprehensive Cancer Center | |
Chapel Hill, North Carolina, United States, 27599-7295 |
Principal Investigator: | Thomas Stinchcombe, MD | The University of North Carolina at Chapel Hill |
Study ID Numbers: | CDR0000542753, LCCC 0519 |
Study First Received: | March 28, 2007 |
Last Updated: | August 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00454324 History of Changes |
Health Authority: | United States: Institutional Review Board |
lung cancer small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Antimitotic Agents Carboplatin Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Paclitaxel Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators Carboplatin |
Antimitotic Agents Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |