Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin

Bladder Cancer Clinical Trial

Official title:

BrUOG 300: Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02030574
• Other study ID #: BrUOG 300
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 20, 2013
• Last updated: June 22, 2015
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: June 2015
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Rhode Island Hospital (including Newport Hospital and East Greenwich)	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	Lifespan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		at approximately 6 months	No
Secondary	Types of toxicities participants experience with neoadjuvant gemcitabine and fractionated cisplatin for patients with bladder cancer.		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)	Yes