Gemcitabine, Cisplatin, and Lenalidomide for Bladder Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier:
First received: September 24, 2011
Last updated: March 14, 2014
Last verified: December 2013


- 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.

Condition Intervention Phase
Ureteral Neoplasms
Urinary Bladder Neoplasms
Urethral Neoplasms
Drug: Lenalidomide
Drug: Cisplatin
Drug: Gemcitabine
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
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)
Intervention Details:
    Drug: Lenalidomide
    Drug: Cisplatin
    Drug: Gemcitabine
  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • Patients greater than or equal to 18 years of age with histological or cytological confirmation of transitional cell carcinoma of the urothelial tract (urethra, bladder, ureters, or renal pelvis), who have measurable disease or unresectable disease (cT4b).
  • Must be registered with the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist .
  • Safety laboratory values and performance status must meet specified limits.
  • Females of childbearing potential must have a negative serum or urine pregnancy test.
  • Males and females must be will to use effective birth control measures (when applicable).
  • Must be able to take aspirin.
  • May not have had prior treatment with systemic chemotherapy for metastatic disease, prior lenalidomide, or surgery (within 30 days of starting study treatment).
  • HIPAA authorization for the release of personal health information is not required for subjects participating at NCI
  Contacts and Locations
Please refer to this study by its identifier: NCT01441050

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Principal Investigator: Andrea B Apolo, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier: NCT01441050     History of Changes
Other Study ID Numbers: 110227, 11-C-0227
Study First Received: September 24, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Renal Pelvis
Transitional Cell Carcinoma
Bladder Cancer
Ureteral Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Ureteral Neoplasms
Urethral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Ureteral Diseases
Urethral Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents processed this record on April 16, 2014