Clinical trial NCT01308840: Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer
Official title: Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Cancer
Gallbladder Cancer
Keywords: Unresectable
metastatic
biliary tract
gallbladder cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2011-03-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy. This study will also examine the potential toxicities, progression-free and overall survival in this population.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic or unresectable Kras and Braf wild-type biliary tract adenocarcinoma (bile ducts, hepatic duct, cystic duct, common bile duct, ampulla of Vater or gallbladder adenocarcinoma).
* Screening for tumor Kras and Braf mutations requires formalin fixed paraffin embedded tumor blocks from core needle excisional biopsy.
* Participants must have measurable disease.
* No prior chemotherapy for biliary tract or gallbladder cancer. Prior chemoembolization or radiation to the liver allowed as long as measurable disease outside chemoembolization or radiation area and other baseline characteristics met and at least 4 weeks has lapsed since therapy. No prior gemcitabine or oxaliplatin or anti-EGFR therapies including panitumumab therapy allowed.
* Age minimum 18 years old.
* Life expectancy of greater than 3 months.
* ECOG performance status \< 1
* Participants must have normal organ and marrow function as defined below:
* Leukocytes \> 3,000/mcL Absolute neutrophil count \> 1,500/mcL Platelets \> 100,000/mcL hemoglobin \> 9mg/dL Mg \> 1.2 mEq/L total bilirubin \< 2.5 mg/dL AST (SGOT)/ALT (SGPT) \< 2.5 X institutional upper limit of normal (unless liver is involved with tumor, in which case the transaminases must be 5 x upper limits of normal), creatinine within normal institutional limits or creatinine clearance \> 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal
* Patients with concurrent malignancy may be included if disease is characterized by one of the following definitions: 1. Malignancy treated with curative intent and with no known active disease present for 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician. 2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease. 3. Adequately treated cervical carcinoma in situ without evidence of disease. 4. Prostatic intraepithelial neoplasia without evidence of prostate cancer. 5. DCIS without evidence of breast cancer.
* Ability to understand and the willingness to sign a written informed consent document.
* Patients may have prior placement of stents or shunts to relieve biliary obstruction.

Exclusion Criteria:

* Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Participants may not be receiving any other study agents.
* Participants with known brain metastases.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, oxaliplatin or panitumumab.
* Patients with preexisting peripheral neuropathy of grade 2 or greater severity according to the Common Terminology Criteria of the NCI (version 3.0) are ineligible.
* Patients with biliary obstruction with inadequate drainage and total bilirubin \> 2.5 mg/dL are ineligible.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements,
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
* Known positive test(s) for HIV, hepatitis C virus, acute or chronic active hepatitis B infection.
* Pregnant women are excluded.

Primary outcomes:
measure: The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
timeFrame: end of cycle 2 of treatment
Secondary outcomes:
measure: Median Progression Free Survival
timeFrame: time to cancer progression or death
measure: Median Overall Survival
timeFrame: enrollment until date of death
measure: The Number of Participants Who Experience an Adverse Event
timeFrame: baseline to study completion
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber / Harvard Cancer Center
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Aram Hezel, MD
role: PRINCIPAL_INVESTIGATOR
References: