Gemcitabine, Cisplatin, and Lenalidomide for Bladder Cancer
- Gemcitabine and cisplatin are common drugs for bladder cancer. Lenalidomide is a drug that limits a tumor's ability to form new blood vessels. By limiting new blood vessel growth, lenalidomide may improve the other drugs' ability to shrink tumors or stop their growth. Researchers are interested in seeing how safe and effective this new drug combination is in treating bladder cancer.
- To test the safety and effectiveness of lenalidomide, gemcitabine, and cisplatin for bladder cancer.
- Individuals at least 18 years of age who have bladder cancer that has not been treated with chemotherapy (excluding chemotherapy given right before or right after surgery to remove the bladder).
- Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
- This study has two separate parts. All participants will have frequent blood tests and imaging studies.
- In the first part, participants will have gemcitabine, cisplatin, and different doses of lenalidomide to find the safest and most effective dose. The chemotherapy will be given in 21-day cycles of treatment, for up to six cycles of treatment.
- After the end of six cycles, participants whose tumors respond to the drugs will have lenalidomide alone for 28-day cycles (21 days on the drug and 7 days off). Treatment will continue for as long as it is effective.
- In the second part, participants will receive lenalidomide alone for one 21-day cycle and then all three drugs for up to six more 21-day cycles. This part will determine how well the drugs can shrink bladder cancers.
Urinary Bladder Neoplasms
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-Center Phase 1B/II Trial of Gemcitabine, Cisplatin, Plus Lenalidomide as First Line Therapy for Patients With Metastatic Urothelial Carcinoma|
- Determine optimal dose of gemcitabine, cisplatin, and lenalidomide. [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
- Determine the 1 year progression-free survival on combination. [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
- Objective response rate by RECIST of gem, cis, lenalidomide combination; safety of combination per CTCAE; evaluate lenalidomide as maintenance treatment; treatment impact on peripheral immune cell subsets and circulating tumos cells. [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
- Safety of combination per CTCAE. [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
- Evaluate lenalidomide as maintenance treatment. [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
- Treatment impact on peripheral immune cell subsets and circulating tumos cells. [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
|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)|