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

NCT01182610 | Terminated Phase 2 Results

• 1 other identifier: ACORN ARCHESO0611
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Response Rate

  The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.

  From the start of study treatment until restaging evaluation performed between days 36 to 43

Secondary Outcomes (4)

• Pathologic Response Rate

  At time of surgery (between days 50 to 64)

• Resection Rate of Surgery

  At time of surgery (between days 50 to 64)

• Thirty-day Surgical Mortality

  From date of surgery to 30 days after date of surgery

• Survival

  2-year survival from first dose of panitumumab

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Drug: Panitumumab; Drug: Paclitaxel; Drug: Carboplatin; Drug: 5FU

Interventions

Panitumumab DRUG

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

Also known as: Vectibix

Treatment group

Paclitaxel DRUG

Paclitaxel 200mg/m2 on Days 1 and 22

Also known as: Taxol

Treatment group

Carboplatin DRUG

Carboplatin AUC=6 on Days 1 and 22

Also known as: Paraplatin, CBDCA

Treatment group

5FU DRUG

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

Also known as: 5-fluorouracil

Treatment group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accelerated Community Oncology Research Network: lead
• Amgen: collaborator

Study Sites (1)

Clopton Clinic

Jonesboro, Arkansas, 72401, United States

Location

MeSH Terms

Interventions

Panitumumab; Paclitaxel; Carboplatin; Fluorouracil

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This study was closed due to notification and preliminary results from a trial including panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the PI, Sponsor, and Funder.

Results Point of Contact

• Title: Vice Presidnet of Scientific Affairs
• Organization: Accelerated Community Oncology Research Network, Inc.

mwalker@acorncro.com

Study Officials

• Robert Hermann, MD

  Accelerated Community Oncology Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 17, 2010
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 3, 2012
• Results First Posted: November 28, 2012

Record last verified: 2012-11

Locations

US (1)