Clinical trial NCT01104350: Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Official title: Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Bladder Cancer
Keywords: Bladder
Radiotherapy
Gemcitabine
Chemotherapy
10-031
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.


Eligibility criteria: Inclusion Criteria:

* MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).
* Karnofsky Performance Scale (KPS) ≥ 70%
* Age ≥18 years old
* Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
* Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin \< 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN
* Adequate renal function: calculated creatinine clearance \> 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance
* Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy.
* Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.
* Previous pelvic radiation therapy
* Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
* Prior cisplatin based neoadjuvant systemic chemotherapy for more than \>4 cycles
* Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
* Women who are pregnant or lactating

Primary outcomes:
measure: To determine the dose limiting toxicity and establish the maximal tolerated dose
timeFrame: 2 years
Secondary outcomes:
measure: To determine the complete response rate of the primary tumor
timeFrame: 4-6 weeks following consolidation therapy
measure: To determine the long term toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marisa Kollmeier, MD
role: PRINCIPAL_INVESTIGATOR
References: