![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118235 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. Giving cisplatin and irinotecan together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and irinotecan together with bevacizumab works in treating patients with extensive-stage small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Biological: bevacizumab Drug: cisplatin Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Cisplatin, Irinotecan and Bevacizumab (NSC #704865, IND #7921) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study |
Study Start Date: | December 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 10-72 patients will be accrued for this study within 7-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer (SCLC)
Extensive-stage disease, defined by 1 of the following:
Measurable or nonmeasurable disease
The following are considered nonmeasurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No hemoptysis
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
Study Chair: | Neal Ready, MD, PhD | Rhode Island Hospital Comprehensive Cancer Center |
Study ID Numbers: | CDR0000433341, CALGB-30306 |
Study First Received: | July 8, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00118235 History of Changes |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer recurrent small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Irinotecan Bevacizumab Angiogenesis Inhibitors Camptothecin Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Irinotecan Bevacizumab Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Camptothecin Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Lung Diseases |