Gemcitabine, Cisplatin, and Lenalidomide for Bladder Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01441050
First received: September 24, 2011
Last updated: May 1, 2013
Last verified: January 2013
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Purpose
Background:
- 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.
Objectives:
- To test the safety and effectiveness of lenalidomide, gemcitabine, and cisplatin for bladder cancer.
Eligibility:
- 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).
Design:
- 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
N/A
Drug: Cisplatin
N/A
Drug: Gemcitabine
N/A
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- INCLUSION AND EXCLUSION CRITERIA:
- 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(Registered Trademark) program, and be willing and able to comply with the requirements of RevAssist(Registered Trademark).
- 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 ClinicalTrials.gov identifier: NCT01441050
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Andrea B Apolo, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) |
| ClinicalTrials.gov Identifier: | NCT01441050 History of Changes |
| Other Study ID Numbers: | 110227, 11-C-0227 |
| Study First Received: | September 24, 2011 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Bladder Renal Pelvis Ureter Urethra |
Transitional Cell Carcinoma Bladder Cancer Ureteral Cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Neoplasms Ureteral Neoplasms Urethral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases Ureteral Diseases Urethral Diseases Gemcitabine Lenalidomide Cisplatin Thalidomide |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013