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

NCT00613730 | Terminated Phase 2 Results

• 1 other identifier: 20060542
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer of Pancreas; Cancer of the Pancreas; Pancreas Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival at 1 Year

  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.

  12 months

Secondary Outcomes (2)

• Progression-free Survival

  Up to 25 months

• Percentage of Participants With Overall Response

  Overall study

Study Arms (1)

Gemcitabine + panitumumab

EXPERIMENTAL

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.

Drug: Gemcitabine; Drug: panitumumab

Interventions

Gemcitabine DRUG

Intravenous administration

Also known as: Gemzar

Gemcitabine + panitumumab

panitumumab DRUG

Intravenous administration

Gemcitabine + panitumumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Competent to comprehend, sign, and date an International Ethics Committee/Institutional Review board (IEC/IRB)-approved informed consent form

You may not qualify if:

• 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
• Prior treatment with gemcitabine
• Patients requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
• Regular use (as determined by the investigator) of nonsteroidal anti-inflammatory agents
• Known allergy to panitumumab or any components of panitumumab formulation or gemcitabine
• Recent infection requiring a course of systemic anti-infectives that was completed ≤ 14 days before enrollment (exception can be made at the judgment of the investigator for oral treatment of an uncomplicated urinary tract infection \[UTI\])

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Panitumumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 6, 2014
• Results First Posted: January 6, 2014

Record last verified: 2013-11