Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Pancrelipase

Panitumumab

Pancreatin

Antimetabolites

Antineoplastic Agents, Immunological

Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.

panitumumab

This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in the United States. In approximately 55 centers, approximately 75 eligible locally advanced unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line therapy of gemcitabine and panitumumab.

Enrollment closed after 3 patients were enrolled. This voluntary action was prompted by the announcement that the Southwest Oncology Group (SWOG) S0205 trial (NCT00075686), A Phase III Randomized Open Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer, did not meet its primary endpoint of improving overall survival).

Adenocarcinoma of the Pancreas Treated With Panitumumab and Gemcitabine Regimen to Investigate Overall Survival as Primary Endpoint

Phase II, Multi-center, Open-label, Single-Arm Study Using Gemcitabine and Panitumumab in the First-line Treatment of Subjects With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

The survival time is calculated from Study Day

1 (ie, the first day that a participant receives study treatment with the gemcitabine regimen in combination with panitumumab) to the date of death due to any cause.

Progression-Free Survival was defined as the time from Study Day 1 to the date of disease progression or the date of death due to any cause (whichever comes earlier). Disease progression is determined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria or per physician's assessment based on symptom progression.

Overall Response defined as the percentage of participants with complete or partial response (CR or PR), as defined by modified RECIST. CR: Disappearance of all target and non-target lesions. PR: Either at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameters (SLD) and no progression of existing non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Gemcitabine + Panitumumab

Age Continuous

Sex: Female, Male

Black or African American

White or Caucasian

Race/Ethnicity, Customized

Study Director

Study was terminated after enrolling 3 participants. This outcome was not evaluated.

Overall Survival at 1 Year

Progression-free Survival

Percentage of Participants With Overall Response

Overall Study

Spots Global Cancer Trial Database for Adenocarcinoma of the Pancreas Treated With Panitumumab and Gemcitabine Regimen to Investigate Overall Survival as Primary Endpoint

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial