This trial is active, not recruiting.

Conditions invasive bladder cancer, bladder cancer
Treatment gemcitabine and fractionated cisplatin (combination treatment)
Phase phase 2
Sponsor Brown University
Collaborator Lifespan
Start date July 2014
End date July 2015
Trial size 26 participants
Trial identifier NCT02030574, BrUOG 300


The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce the size of the cancer in your bladder before surgery and can also help to reduce the chance that your bladder cancer will come back (metastasize) in other parts of your body after bladder surgery.

This study will involve testing cisplatin in lower weekly doses with gemcitabine.The purpose of this study is to test the effects, good and bad, of low dose weekly cisplatin and gemcitabine.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
gemcitabine and fractionated cisplatin (combination treatment)
1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8

Primary Outcomes

Pathologic complete response rate of neoadjuvant gemcitabine and fractionated cisplatin for patients with muscle invasive bladder cancer whom are not candidates for high dose cisplatin.
time frame: at approximately 6 months

Secondary Outcomes

Types of toxicities participants experience with neoadjuvant gemcitabine and fractionated cisplatin for patients with bladder cancer.
time frame: Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Pathologically confirmed muscle-invasive urothelial (transitional cell) carcinoma of the bladder or upper genitourinary tract. 2. Stage T2-T4a. Patients may have nodal disease but there must be no evidence of distant metastases and patients must be candidates for radical cystectomy as determined by urologic surgeon (note from/confirmation by surgeon required). 3. No prior systemic therapy for urothelial carcinoma. Prior intravesical therapy is allowed. 4. Patients are determined by their treating oncologist to not be a candidate high dose cisplatin (> 70mg/m2) due to medical comorbidities. 5. Creatinine Clearance (CrCL or eCCr)) > 25 mL/min calculated using the Cockcroft-Gault formula 6. Patients without serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive the protocol treatment of this study with gemcitabine and weekly fractionated cisplatin. 7. Preexisting neuropathy < grade 2. 8. No prior invasive malignancy within the prior two years. However, prior history of non-muscle invasive bladder cancer and patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer, or asymptomatic prostate cancer) are eligible. 9. ECOG performance status 0 or 1. 10. Age ≥ 18 years of age. 11. Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause or lack of menses >12 months) do not need to have a pregnancy test, please document status. 12. Required Initial Laboratory Values: - Neutrophils ≥ 1,000/μl - Platelet count ≥ 100,000/μl - Total bilirubin ≤ 1.5 x ULN. - AST (SGOT) & ALT (SGPT) ≤ 3.0 x ULN Exclusion Criteria: 1. Metastatic disease. 2. Prior hypersensitivity to platinums that in the investigators opinion would put the patient at risk if re-exposed 3. Small cell cancer of the bladder or pure adenocarcinoma. Patients with mixed histologies such as urothelial carcinoma with sarcomatoid features, squamous differentiation or adenocarcinoma are allowed as long as transitional cell cancer is the predominant pathologic subtype.

Additional Information

Official title BrUOG 300: Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Brown University.