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

Gastroesophageal Adenocarcinoma Clinical Trial

Official title:

A Phase II Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01182610
• Other study ID #: ACORN ARCHESO0611
• Status: Terminated
• Phase: Phase 2
• First received: August 13, 2010
• Last updated: November 29, 2012
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: Accelerated Community Oncology Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Distal Esophagus
• Adenocarcinoma of the Proximal Stomach
• Adenocarcinomas of the Gastroesophageal Junction
• Esophageal Neoplasms
• Gastroesophageal Adenocarcinoma

Intervention

Drug:
• Panitumumab
Panitumumab 9mg/kg on Days 1, 22, and 43
• Paclitaxel
Paclitaxel 200mg/m2 on Days 1 and 22
• Carboplatin
Carboplatin AUC=6 on Days 1 and 22
• 5FU
5FU 225mg/m2/day on Days 1-15 and 22-36

Locations

Country	Name	City	State
United States	Clopton Clinic	Jonesboro	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Accelerated Community Oncology Research Network	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pathologic Response Rate	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.	At time of surgery (between days 50 to 64)	No
Secondary	Resection Rate of Surgery	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.	At time of surgery (between days 50 to 64)	No
Secondary	Thirty-day Surgical Mortality	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.	From date of surgery to 30 days after date of surgery	No
Secondary	Survival		2-year survival from first dose of panitumumab	No