Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer	Drug: Gemcitabine; Drug: Carboplatin; Drug: Panitumumab; Procedure: radical cystectomy	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Study Start Date :	August 2013
Actual Primary Completion Date :	July 2015

Arms and Interventions

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Arm

Intervention/treatment

Experimental: 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.

Drug: Gemcitabine Drug: Carboplatin Drug: Panitumumab Procedure: radical cystectomy

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution
• Alkaline phosphatase ≤ 2.5 x ULN for the institution
• Serum magnesium > 1.4 mEq/L
• Serum creatinine ≤ 2.0 mg/dL
• Cisplatin ineligibility based on one or more of the following criteria:

Estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73m2 using the CKD-EPI equation:(http://nephron.org/MDRD_GFR.cgi) :

eGFR = 141 x min(Scr/k, 1)a x max(Scr/k, 1)-1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black] Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1.

• Grade 2 sensory neuropathy

• Grade 2 hearing loss

  • Patients must provide a pretreatment saliva sample for genomic analysis.

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.
• Pulmonary embolism, deep vein thrombosis, or other significant venous event ≤ 8 weeks before enrollment
• Known allergy or hypersensitivity to any component of the study treatment(s)
• Active infection requiring systemic treatment or any uncontrolled infections ≤14 days prior to enrollment.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
• Concurrent treatment on another clinical trial. Supportive care trials, surgical clinical trials or non-treatment trials, e.g. QOL, are allowed.
• Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg po daily for thromboembolic prophylaxis is allowed).
• Pregnancy or breast-feeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy and for two (2) months following the last dose of panitumumab. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception.

Contacts and Locations

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Locations

United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York, United States

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Amgen

Investigators

Principal Investigator:	Dean Bajorin, MD	Memorial Sloan Kettering Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Memorial Sloan Kettering Cancer Center 

Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01916109 History of Changes
Other Study ID Numbers:	10-103
First Posted:	August 5, 2013
Results First Posted:	February 12, 2016
Last Update Posted:	February 12, 2016
Last Verified:	January 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:

Gemcitabine; Carboplatin; Panitumumab	(GCaP); radical cystectomy; 10-103

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Gemcitabine; Carboplatin; Antibodies, Monoclonal	Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs