Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

NCT ID: NCT01182610

Last Updated: 2012-12-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-03-31

Brief Summary

This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. The expectation is that this combination will both increase potential overall survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease potential surgical mortality by eliminating pre-operative radiation therapy.

Conditions

Gastroesophageal Adenocarcinoma; Adenocarcinoma of the Distal Esophagus; Adenocarcinomas of the Gastroesophageal Junction; Adenocarcinoma of the Proximal Stomach

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Panitumumab 9mg/kg on Days 1, 22, and 43

Paclitaxel 200mg/m2 on Days 1 and 22

Carboplatin AUC=6 on Days 1 and 22

5FU 225mg/m2/day on Days 1-15 and 22-36

Group Type: EXPERIMENTAL

Panitumumab

Intervention Type: DRUG

Panitumumab 9mg/kg on Days 1, 22, and 43

Paclitaxel

Intervention Type: DRUG

Paclitaxel 200mg/m2 on Days 1 and 22

Carboplatin

Intervention Type: DRUG

Carboplatin AUC=6 on Days 1 and 22

5FU

Intervention Type: DRUG

5FU 225mg/m2/day on Days 1-15 and 22-36

Interventions

Panitumumab

Panitumumab 9mg/kg on Days 1, 22, and 43

Intervention Type: DRUG

Paclitaxel

Paclitaxel 200mg/m2 on Days 1 and 22

Intervention Type: DRUG

Carboplatin

Carboplatin AUC=6 on Days 1 and 22

Intervention Type: DRUG

5FU

5FU 225mg/m2/day on Days 1-15 and 22-36

Intervention Type: DRUG

Other Intervention Names

Vectibix; Taxol; Paraplatin, CBDCA; 5-fluorouracil

Eligibility Criteria

Inclusion Criteria

• Biopsy-proven adenocarcinoma of the distal esophagus, gastroesophageal junction, or proximal stomach (within 5cm of gastroesophageal junction)
• No prior treatment for this disease
• AJCC (American Joint Committee on Cancer) clinical stage II to IVA, potentially resectable disease
• Measurable disease per RECIST 1.0 criteria
• Medically fit for surgery; surgical consultation is encouraged prior to initiation of treatment
• ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
• Male or female; aged equal to or greater than 18 years
• Life expectancy of greater than 3 months
• Good organ, metabolic, bone marrow, and pulmonary function as specified in the protocol
• Functioning central venous access device prior to treatment initiation
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for at least 6 months following the last administration of panitumumab
• Ability to understand and the willingness to sign a written IRB (Institutional Review Board) approved informed consent

Exclusion Criteria

• Prior treatment for this disease
• History of another primary cancer except curatively treated in situ cervical cancer, curatively resected nonmelanoma skin cancer, or other primary solid tumor curatively treated with no active disease present and no treatment administered for at least 5 years prior to enrollment
• History or known presence of central nervous system metastases
• History of allergic reactions attributed to compounds similar chemical or biologic composition to panitumumab, paclitaxel, carboplatin, or 5FU
• Prior anti-EGFr-antibody therapy or treatment with small molecule EGFr inhibitors
• Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies within 30 days prior to enrollment
• Chronic use of immunosuppressive agents with the exception of corticosteroids
• Any investigational agent or therapy within 30 days prior to enrollment
• 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 any evidence of interstitial lung disease on baseline chest CT scan
• History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or investigational product(s) administration or may interfere with the interpretation of the results
• Unwilling or unable to comply with study requirements
• Female who tests positive for serum or urine pregnancy test or is breast feeding
• Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
• Major surgery within 28 days or minor surgery within 7 days prior to treatment. Placement of a central venous access device less than one day prior to treatment start
• Male or female of childbearing potential (women who are post-menopausal less than 52 weeks, not surgically sterilized, or not abstinent) not consenting to use adequate contraception prior to study entry and for at least 6 months following the last administration of panitumumab
• Arterial ischemic event (myocardial infarction, stroke) within 3 months prior to enrollment
• Ongoing therapeutic anticoagulation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Accelerated Community Oncology Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Hermann, MD

Role: PRINCIPAL_INVESTIGATOR

Accelerated Community Oncology Research Network

Locations

Clopton Clinic

Jonesboro, Arkansas, United States

Countries

United States

Other Identifiers

ACORN ARCHESO0611

Identifier Type: -

Identifier Source: org_study_id