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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01352962 |
Purpose
Background:
- Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet been approved for use in combination with gemcitabine and carboplatin. Researchers are interested in determining the safest and most effective dose of this combined form of chemotherapy for solid tumors, particularly for urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis).
Objectives:
Eligibility:
Design:
| Condition | Intervention | Phase |
|---|---|---|
|
Urethral Neoplasms Neoplasms, Urethral Ureter Cancer Cancer of the Urethra Urethral Cancer |
Drug: Gemcitabine Drug: Carboplatin Drug: Lenalidomide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Gemcitabine, Carboplatin and Lenalidomide (GCL) for Treatment of Patients With Advanced/Metastatic Urothelial Carcinoma (UC) and Other Solid Tumors |
| Estimated Enrollment: | 42 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Those patients that develop DVTs during the study will be treated with anticoagulants and in certain cases, will continue on the protocol.
INCLUSION OF WOMEN AND MINORITIES:
Both men and women of all races and ethnic groups are eligible for this trial.
Contacts and Locations| Contact: Melony A Beatson, R.N. | (301) 435-5614 | beatsonm@mail.nih.gov |
| Contact: Andrea B Apolo, M.D. | (301) 496-4916 | apoloab@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937 | |
| Principal Investigator: | Andrea B Apolo, M.D. | National Cancer Institute (NCI) |
More Information
| Responsible Party: | Andrea B. Apolo, M.D./National Cancer Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT01352962 History of Changes |
| Other Study ID Numbers: | 110140, 11-C-0140 |
| Study First Received: | May 11, 2011 |
| Last Updated: | May 3, 2012 |
| Health Authority: | United States: Federal Government |
|
Dose Limiting Toxicity Urethra Cancer Carcinoma of the Bladder Cancer of the Renal Pelvis Ureter Cancer |
Urethral Cancer Solid Tumor Pancreatic Cancer Ovarian Cancer Non-Small Cell Lung Cancer |
|
Neoplasms Urethral Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urethral Diseases Urologic Diseases Ureteral Diseases Gemcitabine Thalidomide Lenalidomide Carboplatin Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Leprostatic Agents Anti-Bacterial Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents |