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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01182610
• Date of registration: 13/08/2010
• Primary sponsor: Accelerated Community Oncology Research Network
• Public title: Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma
• Scientific title: A Phase II Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma
• Date of first enrolment: April 2011
• Target sample size: 1
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01182610
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Robert Hermann, MD
• Affiliation: Accelerated Community Oncology Research Network

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Adenocarcinoma of the Distal Esophagus

Adenocarcinoma of the Proximal Stomach

Adenocarcinomas of the Gastroesophageal Junction

Gastroesophageal Adenocarcinoma

Intervention(s)

Drug: panitumumab, paclitaxel, carboplatin, and continuous infusion 5FU

Primary Outcome(s)

Response rate [Time Frame: From the start of study treatment until restaging evaluation performed between days 36 to 43]

Secondary Outcome(s)

Pathologic response rate [Time Frame: At time of surgery (between days 50 to 64)]

Resection rate of surgery [Time Frame: At time of surgery (between days 50 to 64)]

Survival [Time Frame: 2-year survival from first dose of panitumumab]

Thirty-day surgical mortality [Time Frame: From date of surgery to 30 days after date of surgery]

Secondary ID(s)

ACORN ARCHESO0611

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amgen