Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gallbladder Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Biliary Tract Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Oxaliplatin

Panitumumab

Antimetabolites

Antineoplastic Agents, Immunological

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)

oxaliplatin

gemcitabine

Aram Hezel, MD

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.

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

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.

Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

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

Amgen

University of Rochester

Professor

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)

Panitumumab: Day 1 and 15 = 6 mg/kg IV

oxaliplatin: Days 1 and 15 = 85mg/m2 IV

gemcitabine: Days 1 and 15 = 1000 mg/m2 IV

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

ECOG describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. It ranges from 0-5 with higher numbers indicating reduced ability to care for themself.

Eastern Cooperative Oncology Group (ECOG) Performance status

locally advanced

metastatic

Extent of disease

intrahepatic cholangiocarcinoma

gallbladder

extrahepatic cholantiocarcinoma

primary tumor site

lymph nodes

lung

bone

omentum/peritoneal

adrenal

pelvic soft tissue

metastases

Aram F Hezel

complete response

partial response

stable disease

progressive disease

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.

Median Progression Free Survival

Median Overall Survival

The Number of Participants Who Experience an Adverse Event

Overall Study

Spots Global Cancer Trial Database for Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial