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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01916109
First received: August 2, 2013
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Bladder Cancer
Drug: Gemcitabine
Drug: Carboplatin
Drug: Panitumumab
Procedure: radical cystectomy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • pathologic complete response rate (<pT0) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.

  • safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The frequency and severity of toxicities will be tabulated according to the NCI common toxicity criteria version 4.0.


Secondary Outcome Measures:
  • pathologic response rate (<pT2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.

  • disease progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time to progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.

  • overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    overall survival will be estimated using the methods of Kaplan and Meier.


Estimated Enrollment: 38
Study Start Date: August 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916109

Contacts
Contact: Dean Bajorin, MD 646-422-4333
Contact: Jonathan Rosenberg, MD 646-422-4461

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Dean Bajorin, MD    646-422-4333      
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Dean Bajorin, MD    646-422-4333      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dean Bajorin, MD    646-422-4333      
Contact: Jonathan Rosenberg, MD    646-422-4461      
Principal Investigator: Dean Bajorin, MD         
Memorial Sloan-Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Dean Bajorin, MD    646-422-4333      
Memoral Sloan Kettering Cancer Center@Phelps Recruiting
Sleepy Hollow, New York, United States
Contact: Dean Bajorin, MD    646-422-4333      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Amgen
Investigators
Principal Investigator: Dean Bajorin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01916109     History of Changes
Other Study ID Numbers: 10-103
Study First Received: August 2, 2013
Last Updated: November 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Gemcitabine
Carboplatin
Panitumumab
(GCaP)
radical cystectomy
10-103

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Antibodies, Monoclonal
Carboplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014