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

NCT ID: NCT02030574

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-06-30

Brief 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.

Conditions

Invasive Bladder Cancer; Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Gemcitabine and fractionated cisplatin (combination treatment)

Intervention Type: DRUG

1 Cycle = 21 days. GC x 4 cycles ----\> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifespan

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Jodi Layton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rhode Island Hospital (including Newport Hospital and East Greenwich)

Providence, Rhode Island, United States

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

BrUOG 300

Identifier Type: -

Identifier Source: org_study_id