Phase II Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine
- Conditions
- Bladder Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 4
- Locations
- 5
- Primary Endpoint
- Pathologic Complete Response Rate (<pT0)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to find out if using the combination of standard chemotherapy (gemcitabine and carboplatin) plus this new drug (panitumumab) can help to shrink the tumor before the patient undergoes surgery for bladder cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed muscle invasive transitional cell carcinoma of the bladder at MSKCC (Note: urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or EUA.)
- •Clinical stage T2-T4a N0/X M0 disease.
- •Medically appropriate candidate for radical cystectomy as per MSKCC attending urologic oncologist
- •Karnofsky Performance Status ≥ 80%
- •Age ≥ 18 years of age
- •Required Initial Laboratory Values:
- •Absolute neutrophil count ≥ 1500 cells/mm3
- •Platelets ≥ 100,000 cells/mm3
- •Hemoglobin ≥ 9.0g/dL
- •Bilirubin ≤ 1.5 the upper limit of normal (ULN) for the institution
Exclusion Criteria
- •Prior systemic chemotherapy (prior intravesical therapy is allowed)
- •Serious intercurrent medical or psychiatric illness.
- •Prior radiation therapy to the bladder.
- •Concomitant use of any other investigational drugs
- •Any of the following within the 6 months prior to study drug administration: myocardial infarction, grade 2 or greater peripheral vascular disease, arterial thrombotic event, visceral arterial ischemia, cerebrovascular ischemia, transient ischemic attack, percutaneous transluminal angioplasty or stent, or unstable angina.
- •Symptomatic and/or serious uncontrolled arrhythmia
- •Symptomatic congestive heart failure (NYHA class III or IVI)
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
- •Major surgery requiring general anesthesia within 21 days or minor surgery within 14 days of study enrollment. Subjects must have recovered from surgery related toxicities.
Arms & Interventions
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
Patients will receive four cycles of GCaP administered every 21 days. Panitumumab will be administered intravenously at a dose of 9mg/kg on day 1. Gemcitabine 1,000 mg/m2 on day 1 and 8 and carboplatin AUC 4.5 on day 1 will be administered intravenously on a 21-day cycle. A total of four cycles of therapy will be administered at 21-day intervals followed by radical cystectomy.
Intervention: Gemcitabine
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
Patients will receive four cycles of GCaP administered every 21 days. Panitumumab will be administered intravenously at a dose of 9mg/kg on day 1. Gemcitabine 1,000 mg/m2 on day 1 and 8 and carboplatin AUC 4.5 on day 1 will be administered intravenously on a 21-day cycle. A total of four cycles of therapy will be administered at 21-day intervals followed by radical cystectomy.
Intervention: Carboplatin
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
Patients will receive four cycles of GCaP administered every 21 days. Panitumumab will be administered intravenously at a dose of 9mg/kg on day 1. Gemcitabine 1,000 mg/m2 on day 1 and 8 and carboplatin AUC 4.5 on day 1 will be administered intravenously on a 21-day cycle. A total of four cycles of therapy will be administered at 21-day intervals followed by radical cystectomy.
Intervention: Panitumumab
Gemcitabine, Carboplatin, and Panitumumab (GCaP)
Patients will receive four cycles of GCaP administered every 21 days. Panitumumab will be administered intravenously at a dose of 9mg/kg on day 1. Gemcitabine 1,000 mg/m2 on day 1 and 8 and carboplatin AUC 4.5 on day 1 will be administered intravenously on a 21-day cycle. A total of four cycles of therapy will be administered at 21-day intervals followed by radical cystectomy.
Intervention: radical cystectomy
Outcomes
Primary Outcomes
Pathologic Complete Response Rate (<pT0)
Time Frame: 1 year
The absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.