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Adenocarcinoma of the Pancreas Treated With Panitumumab and Gemcitabine Regimen to Investigate Overall Survival as Primary Endpoint | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT00613730•Amgen

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women ≥ 18 and ≤ 75 years of age
•Histologically or cytologically confirmed pancreatic adenocarcinoma meeting one of the following criteria: Locally advanced unresectable disease, or metastatic disease
•Measurable or unmeasurable disease
•Patients with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, bilary, gastrointestinal bypass) are eligible, if the patient has fully recovered from surgery and ≥ 28 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence
•Karnofsky performance score ≥ 60 %
•Life expectancy of ≥ 12 weeks as documented by the investigator
•Hematologic function, as follows: Absolute neutrophils count (ANC) ≥ 1.5 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, and hemoglobin ≥ 9.0 g/dL
•Renal function, as follows: Serum creatinine ≤ 1.5 mg/dL
•Hepatic function, as follows: Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) (if liver metastases ≤ 5 x ULN), alanine aminotransferase (ALT) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN), and total bilirubin ≤ 2.0 mg/dL. Patients with history of biliary obstruction are eligible after intervention, once this criteria is met.
•Metabolic function, as follows: Magnesium ≥ lower limit of normal, and calcium ≥ lower limit of normal
+1 more criteria

Exclusion Criteria

•Islet cell or acinar cell carcinoma or cystadenocarcinoma
•History or known presence of central nervous system (CNS) mestatases
•History of another primary cancer, except: Curatively treated cervical carcinoma in situ, or curatively resected non-melanomatous skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment
•Other concurrent anticancer chemotherapy
•Concomitant malignant disease
•Prior radiotherapy ≤ 14 days, or if subjects has not recovered from radiotherapy
•Uncontrolled seizure disorder or other serious neurological diseases
•Any co-morbid disease that would increase risk of toxicity
•Prior anti-Epidermal growth factor receptor (EGFr) antibody or Vascular endothelial growth factor (VEGF) therapy (eg, cetuximab, bevacizumab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
•Adjuvant chemotherapy or chemoradiotherapy ≥ 24 weeks prior to enrollment
+16 more criteria

Key Dates

Start Date

January 1, 2007

Primary Completion Date

April 1, 2009

Completion Date

April 1, 2009

Last Updated

January 6, 2014

Enrollment

ACTUAL participants

Conditions

Cancer of PancreasCancer of the PancreasPancreas CancerPancreatic Cancer

Interventions

Gemcitabine

DRUG

panitumumab

DRUG

Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

NCT04485286

Lung CancerRadiation Fibrosis+2 more

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RECRUITINGPHASE1/PHASE2

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

NCT04605913

Pancreas CancerMetastatic Pancreatic Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

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