Gemcitabine, Cisplatin, Plus Lenalidomide as First-line Therapy for Patients With Metastatic Urothelial Carcinoma

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are (Phase 1) to determine in subjects with unresectable or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to study this recommended dose in subjects to evaluate progression-free survival at 1 year. The secondary objectives will be to determine the objective response rate to treatment, and the safety of combination therapy with gemcitabine, cisplatin and lenalidomide as well as to evaluate lenalidomide as maintenance treatment in subjects achieving objective response or stable disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Celgene; Celgene Corporation
• Treatments: Cisplatin; Gemcitabine; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

2. Age > 18 years at the time of consent.

3. Karnofsky Performance Status of ≥ 70%.

4. Histological or cytological proof of transitional cell carcinoma of the urothelial tract. The primary site may include: urethra, bladder, ureters, and renal pelvis. Patients with mixed histologies may be enrolled provided that transitional cell carcinoma is the predominant histology.

5. Measurable disease according to RECIST or unresectable disease (cT4b).

6. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

7. Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.

8. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

9. Adequate organ function as determined by the following laboratory values:

• Hemoglobin (Hgb) > 9 g/dL

• Platelets > 100 x 1,000,000,000/L

• Absolute neutrophil count (ANC) > 1.5 x 1,000,000,000/L

• Calculated creatinine clearance of > 60 cc/min using the Cockcroft-Gault formula

• Bilirubin < 1.5 x ULN

• Aspartate aminotransferase (AST, SGOT) < 1.5 X ULN (< 5 X ULN if patient has hepatic metastases)

Exclusion Criteria:

1. Has had prior treatment with systemic chemotherapy for metastatic disease (prior intravesical therapy is permitted; prior neoadjuvant/adjuvant chemotherapy permitted if completed ≥ 1 year from study entry)

2. Has received prior lenalidomide.

3. Has had major surgery within 30 days of starting the study treatment

4. Has had any of the following within the 6 months prior to study drug administration:

myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism

5. Has active CNS metastases. Subjects with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.

6. Has a history of a prior malignancy

7. Has received anticancer therapy, radiation, or any investigational agent within 30 days prior to being registered for protocol therapy.

8. Pregnant or breastfeeding.

9. Has a clinically significant infection as judged by the treating investigator.

10. Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).