Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer (UGIH09067)

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01308840
First received: August 9, 2010
Last updated: January 31, 2013
Last verified: January 2013

August 9, 2010
January 31, 2013
December 2010
January 2013   (final data collection date for primary outcome measure)
To determine the radiographic response rate of GEMOX-Panitumumab (GEMOX-P) in chemotherapy naïve KRAS/ BRAF wild type stage IV BTC [ Time Frame: Evaluation at every 8 weeks and thereafter. Responses must be ] [ Designated as safety issue: No ]
Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.
Same as current
Complete list of historical versions of study NCT01308840 on ClinicalTrials.gov Archive Site
Evaluate the toxicities of GEMOX-P regimen in this population. Evaluate the preliminary efficacy of GEMOX-P regimen including progression free survival, and overall survival in this population. [ Time Frame: Patients will be followed until death ] [ Designated as safety issue: Yes ]
Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event
Same as current
Not Provided
Not Provided
 
Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer
Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Biliary Tract Cancer
  • Gallbladder Cancer
  • Drug: Panitumumab
    Day 1 and 15 = 6 mg/kg IV
    Other Name: GEMOX-Panitumumab (GEMOX-P)
  • Drug: oxaliplatin
    Days 1 and 15 = 85mg/m2 IV
  • Drug: gemcitabine
    Days 1 and 15 = 1000 mg/m2 IV
Experimental: Panitumumab
Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Interventions:
  • Drug: Panitumumab
  • Drug: oxaliplatin
  • Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01308840
UGIH09067
Yes
University of Rochester
University of Rochester
Amgen
Principal Investigator: Aram Hezel, MD University of Rochester
University of Rochester
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP