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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00792545 |
Purpose
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 solid tumors by blocking blood flow to the tumor. Giving dasatinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib given together with bevacizumab in treating patients with solid tumor that is metastatic or cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Gastrointestinal Stromal Tumor Intraocular Melanoma Kidney Cancer Lung Cancer Melanoma (Skin) Ovarian Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Biological: bevacizumab Drug: dasatinib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label |
| Official Title: | A Phase I Study of Dasatinib in Combination With Bevacizumab in Advanced Solid Tumors |
| Estimated Enrollment: | 48 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I (Group 2): Experimental
In course 1, patients receive oral dasatinib alone once daily on days 1-28. Beginning in course 2 and for all subsequent courses, patients receive oral dasatinib once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: dasatinib
Given orally
|
|
Arm II (Group 2): Experimental
In course 1, patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Beginning in course 2 and for all subsequent courses, patients receive oral dasatinib once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: dasatinib
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of dasatinib and bevacizumab (group 1) followed by a randomized study (group 2).
Group 2: Patients receive dasatinib and bevacizumab at the maximum tolerated dose determined in group 1. Patients are randomized to 1 of 2 treatment arms.
Patients in group 2 undergo tumor biopsies and dynamic contrast-enhanced MRI at baseline, after 2 weeks of single-agent therapy, and after ≥ 2 weeks of combined therapy to examine biochemical effects of treatment and to evaluate changes in vascularity and quality of index lesions. Blood samples are also collected from these patients and archived for future studies, including cytokine and invasion marker analysis and circulating endothelial cell analysis.
After completion of study therapy, patients are followed for 4 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or unresectable malignant solid tumors, including but not limited to, any of the following:
Patients enrolling in group 2 must have at least one lesion deemed safe to biopsy and be willing to undergo the three mandatory biopsies
Patients with pleural effusion are eligible provided it was tapped prior to study
No brain metastases
PATIENT CHARACTERISTICS:
Spot urine protein:creatinine ratio ≤ 0.5 OR 24-hour urine for protein excretion ≤ 1,000 mg
No thrombotic or embolic events within the past 6 months, including any of the following:
No concurrent uncontrolled illness including, but not limited to, any of the following:
Ongoing or active infection
No clinically significant cardiovascular disease including any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior chemotherapy, radiotherapy, hormonal therapy, or biological therapy
No other concurrent investigational agents or anticancer agents including hormonal therapy (except for bisphosphonates or erythropoietin analogs)
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| Principal Investigator: | Elise C. Kohn, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000620032, NCI-09-C-0019 |
| Study First Received: | November 16, 2008 |
| Last Updated: | September 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00792545 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer recurrent ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian germ cell tumor stage III ovarian germ cell tumor stage IV ovarian germ cell tumor ovarian sarcoma ovarian stromal cancer gastrointestinal stromal tumor recurrent melanoma stage III melanoma |
stage IV melanoma recurrent prostate cancer stage III prostate cancer stage IV prostate cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer extensive stage small cell lung cancer large cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent breast cancer male breast cancer |
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Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Prostatic Diseases Physiological Effects of Drugs Urogenital Neoplasms Bevacizumab Urologic Neoplasms Protein Kinase Inhibitors Neoplasms by Site Lung Neoplasms Therapeutic Uses Dasatinib Kidney Diseases Angiogenesis Modulating Agents Breast Diseases |
Endocrine Gland Neoplasms Digestive System Neoplasms Eye Neoplasms Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Carcinoma Neuroectodermal Tumors Neoplasms Lung Diseases Gastrointestinal Neoplasms Prostatic Neoplasms Neoplasms, Glandular and Epithelial Genital Neoplasms, Male |