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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01916109
• Other study ID #: 10-103
• Status: Terminated
• Phase: Phase 2
• First received: August 2, 2013
• Last updated: January 14, 2016
• Start date: August 2013

Study information

• Verified date: January 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Gemcitabine

• Carboplatin

• Panitumumab

Procedure:
• radical cystectomy

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering at Mercy Medical Center	Rockville Centre	New York
United States	Memoral Sloan Kettering Cancer Center@Phelps	Sleepy Hollow	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Memorial Sloan Kettering Cancer Center