Status:
COMPLETED
Neoadjuvant Dasatinib and Radical Cystectomy for Transitional Cell Carcinoma of the Bladder
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Transitional Cell Carcinoma of the Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study is designed to determine feasibility and safety of treatment with dasatinib administered orally once daily for 4 weeks duration prior to radical cystectomy for urothelial carcinoma of...
Detailed Description
OUTLINE: This is a multi-center study. This is a pilot study designed to determine the safety and feasibility of treatment with dasatinib 100 mg administered orally once daily for 4 weeks duration pr...
Eligibility Criteria
Inclusion
- Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-IVa) with no evidence of metastatic disease (focal squamous and/or adenocarcinoma differentiation defined as ≤ 10% of tumor volume allowed, sarcomatoid and small-cell components not allowed). Patient with any degree of fixation of the pelvic sidewall are not eligible.
- Patients must be willing to undergo a Cystoscopy, prior to registration on study if tumor block is not available.
- Eligible for radical cystectomy as per the attending urologist.
- All patients must be willing to forego neoadjuvant cisplatin-based combination chemotherapy and understand it is an option post-surgery or must be deemed ineligible for cisplatin-based combination chemotherapy by the attending medical oncologist.
- Prior radiation therapy is allowed provided that no radiation therapy was administered to the urinary bladder.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age \> 18 years at the time of consent.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
- Females must not be breastfeeding.
- Ability to take oral medication (dasatinib must be swallowed whole).
Exclusion
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason \< grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 5 years.
- No treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
- No prior systemic chemotherapy for transitional cell carcinoma of the bladder( prior intravesical therapy is allowed). Any other prior chemotherapy must have been completed \> 5 years prior to initiation of therapy.
- Following concomitant medications must be discontinued 7 days prior to registration on study and for the duration of dasatinib therapy: Bisphosphonates - due to risk of hypocalcemia; Drugs that are generally accepted to have a risk of causing Torsades de Pointes; any prohibited CYP3A4 inhibitors/inducers/substrates; Anti-coagulation and/or anti-platelet therapies to avoid potential bleeding risks.
- No clinically significant infections as judged by the treating investigator.
- No pleural or pericardial effusion of any grade.
- history of diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- No history of diagnosed acquired bleeding disorder (e.g., acquired anti-factor VIII antibodies) within one year prior to registration on protocol therapy.
- No history of ongoing or recent (within \<3 months prior to registration on protocol therapy) significant gastrointestinal bleeding.
- No known history of hypokalemia that cannot be corrected prior to registration on protocol therapy.
- No known history of hypomagnesemia that cannot be corrected prior to registration on protocol therapy.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00706641
Start Date
June 1 2008
End Date
December 1 2012
Last Update
January 15 2016
Active Locations (3)
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1
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
Baylor College of Medicine
Houston, Texas, United States, 77030
3
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502