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

NCT01308840 | Completed Phase 2 Results DMC

• 1 other identifier: UGIH09067
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Biliary Tract Cancer; Gallbladder Cancer

Keywords

Unresectable; metastatic; biliary tract; gallbladder cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  end of cycle 2 of treatment

Secondary Outcomes (3)

• Median Progression Free Survival

  time to cancer progression or death

• Median Overall Survival

  enrollment until date of death

• The Number of Participants Who Experience an Adverse Event

  baseline to study completion

Study Arms (1)

Panitumumab

EXPERIMENTAL

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)

Drug: Panitumumab; Drug: oxaliplatin; Drug: gemcitabine

Interventions

Panitumumab DRUG

Day 1 and 15 = 6 mg/kg IV

Also known as: GEMOX-Panitumumab (GEMOX-P)

Panitumumab

oxaliplatin DRUG

Days 1 and 15 = 85mg/m2 IV

Panitumumab

gemcitabine DRUG

Days 1 and 15 = 1000 mg/m2 IV

Panitumumab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Amgen: collaborator

Study Sites (2)

Dana-Farber / Harvard Cancer Center

Boston, Massachusetts, 02215, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Gallbladder Neoplasms; Neoplasm Metastasis

Interventions

Panitumumab; Oxaliplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Aram F Hezel
• Organization: University of Rochester

aram_hezel@urmc.rochester.edu

585-275-5823

Study Officials

• Aram Hezel, MD

  University of Rochester

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: March 4, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 17, 2016
• Results First Posted: August 17, 2016

Record last verified: 2016-07

Locations

US (2)