Gemcitabine, Carboplatin, and Lenalidomide for Treatment of Advanced/Metastatic Urothelial Cancer and Other Solid Tumors
|ClinicalTrials.gov Identifier: NCT01352962|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2011
Last Update Posted : February 14, 2018
- 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).
- To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for solid tumor cancers.
- To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for urothelial (bladder) cancer.
- Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatments.
- Individuals at least 18 years of age who have been diagnosed with urothelial cancer that has not responded to standard treatments.
- Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies.
- Participants with urothelial cancer will receive lenalidomide alone for the first 14 days of a 21-day cycle before starting the first full treatment cycle.
- All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1 only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the first 14 days of each cycle. Participants will be asked to take aspirin or other medications to prevent the possibility of blood clots.
- Participants may receive up to six cycles of treatment with this combination. If after six cycles the cancer has not grown or has shrunk, participants may continue to take lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until the cancer recurs.
- Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment.
- After the end of the last treatment cycle, participants will have followup visits every 3 months for the next 18 months, then every 6 months for another 18 months, and then yearly.
|Condition or disease||Intervention/treatment||Phase|
|Urethral Neoplasms Neoplasms, Urethral Ureter Cancer Cancer of the Urethra Urethral Cancer||Drug: Gemcitabine Drug: Carboplatin Drug: Lenalidomide||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 11, 2011|
|Actual Primary Completion Date :||February 7, 2017|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: Arm 1
Standard of Care plus escalating dosesof Lenalidomide
1,000mg/m2 IVPB over 30 min x 1Drug: Carboplatin
AUC 5** IVPB over 30 min x 1Drug: Lenalidomide
Escalating Doses starting at 2.5 po daily up to 25 mg po daily until MTD is reached.
- Dose limiting toxicity [ Time Frame: Maximum Tolerated Dose ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352962
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Andrea B Apolo, M.D.||National Cancer Institute (NCI)|