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

This study is not yet open for participant recruitment.
Verified January 2014 by Brown University
Sponsor:
Information provided by (Responsible Party):
Jodi Layton, Brown University
ClinicalTrials.gov Identifier:
NCT02030574
First received: December 20, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Invasive Bladder Cancer
Bladder Cancer
Drug: Gemcitabine and fractionated cisplatin (combination treatment)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BrUOG 300: Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02030574

Contacts
Contact: kayla rosati 4018633000 kayla_rosati@brown.edu

Locations
United States, Rhode Island
The Miriam Hospital Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: kayla rosati    401-863-3000    kayla_rosati@brown.edu   
Principal Investigator: Jodi Layton, MD         
Rhode Island Hospital Not yet recruiting
Providence, Rhode Island, United States, 02903
Contact: Kayla Rosati, EdM    401-863-3000    kayla_rosati@brown.edu   
Principal Investigator: Jodi Layton, MD         
Sponsors and Collaborators
Brown University
  More Information

No publications provided

Responsible Party: Jodi Layton, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT02030574     History of Changes
Other Study ID Numbers: BrUOG 300
Study First Received: December 20, 2013
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Cisplatin
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

ClinicalTrials.gov processed this record on April 17, 2014