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

This study has been terminated.
(Safety concern in a similar trial enrolling the same patient population)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT01182610
First received: August 13, 2010
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Adenocarcinoma
Adenocarcinoma of the Distal Esophagus
Adenocarcinomas of the Gastroesophageal Junction
Adenocarcinoma of the Proximal Stomach
Drug: Panitumumab
Drug: Paclitaxel
Drug: Carboplatin
Drug: 5FU
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Accelerated Community Oncology Research Network:

Primary Outcome Measures:
  • Response Rate [ Time Frame: From the start of study treatment until restaging evaluation performed between days 36 to 43 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pathologic Response Rate [ Time Frame: At time of surgery (between days 50 to 64) ] [ Designated as safety issue: No ]
    The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H&E) examination.

  • Resection Rate of Surgery [ Time Frame: At time of surgery (between days 50 to 64) ] [ Designated as safety issue: No ]

    The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H&E)examination, and the operative report indicates complete resection with no residual disease.

    The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H&E) examination, and the operative report indicates complete resection with no residual disease.

    The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease.


  • Thirty-day Surgical Mortality [ Time Frame: From date of surgery to 30 days after date of surgery ] [ Designated as safety issue: No ]
    All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.

  • Survival [ Time Frame: 2-year survival from first dose of panitumumab ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Drug: Panitumumab
Panitumumab 9mg/kg on Days 1, 22, and 43
Other Name: Vectibix
Drug: Paclitaxel
Paclitaxel 200mg/m2 on Days 1 and 22
Other Name: Taxol
Drug: Carboplatin
Carboplatin AUC=6 on Days 1 and 22
Other Name: Paraplatin, CBDCA
Drug: 5FU
5FU 225mg/m2/day on Days 1-15 and 22-36
Other Name: 5-fluorouracil

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182610

Locations
United States, Arkansas
Clopton Clinic
Jonesboro, Arkansas, United States, 72401
Sponsors and Collaborators
Accelerated Community Oncology Research Network
Amgen
Investigators
Principal Investigator: Robert Hermann, MD Accelerated Community Oncology Research Network
  More Information

No publications provided

Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT01182610     History of Changes
Other Study ID Numbers: ACORN ARCHESO0611
Study First Received: August 13, 2010
Results First Received: October 30, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014