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

NCT01916109 | Terminated Phase 2 Results

• 1 other identifier: 10-103
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 5

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.

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate (<pT0)

  The absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.

  1 year

Study Arms (1)

Gemcitabine, Carboplatin, and Panitumumab (GCaP)

EXPERIMENTAL

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

Interventions

Gemcitabine DRUG

Gemcitabine, Carboplatin, and Panitumumab (GCaP)

Carboplatin DRUG

Gemcitabine, Carboplatin, and Panitumumab (GCaP)

Panitumumab DRUG

Gemcitabine, Carboplatin, and Panitumumab (GCaP)

radical cystectomy PROCEDURE

Gemcitabine, Carboplatin, and Panitumumab (GCaP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Amgen: collaborator

Study Sites (5)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Cone Dystrophy 3

Interventions

Gemcitabine; Carboplatin; Panitumumab; Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Dean Bajorin
• Organization: Memorial Sloan Kettering Cancer Center

bajorind@mskcc.org

646-422-4333

Study Officials

• Dean Bajorin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 5, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2015
• Last Updated: February 12, 2016
• Results First Posted: February 12, 2016

Record last verified: 2016-01

Locations

US (5)