Return to List

Study Summary
No. ACOSOGZ4051:.......Esophagus; Gastrointestine......Wayne L. Hofstetter......Thoracic & Cardiovascular
.
Study Summary Title
Study Summary
Number:
ACOSOGZ4051
Study Title:A Phase II Study of Neoadjuvant Therapy with Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients with Locally Advanced Adenocarcinoma of the Distal Esophagus
.
Physician New Patient Referral
Name:Wayne L. HofstetterPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Thoracic & CardiovascularReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-9152
Contact us about clinical trials
.
General Information
Disease Group:Esophagus
Gastrointestine
Supported By:ACOSOG
Phase of Study:Phase IIReturn
Visit:
Every 2 weeks for 4 weeks of the study, Daily (Monday through Friday) during
weeks 5 through 9 of the study (28 days), for surgery 6 - 9 weeks after
treatment ends, 30 days post-op, every 3 months for the next 2 years, every 6
months for one year
Treatment
Agents:
Cisplatin
Panitumumab
Radiation
Taxotere
Home Care:None
Treatment Loc:Both at MDACC & Community Programs (CCOP/Network)
Estimated
Length of Stay
in Houston:
Chemotherapy and radiation therapy will be given on an outpatient basis.
Hospitalization will be related to surgery, expected stay is 10 - 12 days
Description/
Intervention:
The goal of this clinical research study is to learn if using panitumumab in
combination with chemotherapy (cisplatin and docetaxel) and radiation before
surgery can help to control cancer of the esophagus. The safety of this
treatment combination will also be studied.
.
Study Objectives / Outcomes
This study will assess whether the addition of Panitumumab to concurrent induction chemotherapy followed by chemoradiation in patients with locally advanced adenocarcinoma of the distal esophagus will result in significantly improved pathologic complete response (pCR) rates (no residual tumor in the primary or lymph nodes).

Primary Objective
To determine the pCR rate for patients with adenocarcinoma of the esophagus and gastroesophageal junction treated with neoadjuvant Panitumumab and combination chemoradiation.

Secondary Objectives
1. To determine the near-complete pathologic response rate in the primary tumor (<10% residual viable cancer)
    2. To determine the overall survival and disease-free survival rates.
      3. To determine the safety profile of the proposed regimen.

          4. To determine the value of DNA hypermethylation as a predictor of response and survival in patients with distal esophageal adenocarcinoma treated with chemoradiation followed by surgery.
      .
      Study Status Information
      Study Activation / Registration Date:03/25/2010
      IRB Review and Approval Date:03/25/2010
      Study Type:Phase Ii Or Phase I/Ii
      Recruitment Status:Closed
      Projected Accrual:69
      .
      Enrollment Eligibility
      If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

      Inclusion Criteria:1) >/= 18 years old.

      2) ECOG/Zubrod Performance Status 0-1

      3) Biopsy -proven resectable primary (nonrecurrent) adenocarcinoma of the distal esophagus or GE junction (Siewert Type I or II). Siewert Type definitions: Siewert Type I: adenocarcinoma of the distal esophagus Siewert Type II: adenocarcinoma of the esophago-gastric junction/real cardia

      4) Pre-registration EUS, CT of chest and upper abdomen, and PET must support a clinical stage ofT1-3N1M0, T3N0M0 or T1-3N0-1M1a (celiac adenopathy must be </= 2 cm by EUS). Clinically staged T1N0M0 and T2N0M0 tumors are not eligible. N1 does not require biopsy/FNA. Note: Patients requiring a stent for nutrition must have staging examinations and scans completed before stent placement.

      5) No definitive radiological evidence of distant metastases.

      6) No pre-existing grade 2 or greater peripheral neuropathy of any etiology.

      7) Adequate bone marrow, hepatic and renal function prior to registration: WBC >/= 3000/mm^3, ANC >/= 1,500/mm^3, Hemoglobin >/= 9.5 mg/dl, Platelet count >/= 100,000/mm^3, Creatinine </= 1.5 mg/dl, Total Bilirubin </= 3 mg/dl, AST (SGOT) </= 2.0 times ULN, ALT (SGPT) </= 2.0 times ULN, Alkaline Phosphatase </= 2.0 times ULN, Albumin >/= 2.0 g/dl or prealbumin >/= 15 mg/dl, Magnesium >/= LLN

      8) Patient must be evaluated before registration by medical oncologist, radiation oncologist and surgeon and deemed fit for protocol therapy and surgery.

      9) No prior invasive malignancy, unless disease-free for >/= 5 years (Exceptions: non-melanoma skin cancer, in-situ cancers).

      10) Non-pregnant and non-breast-feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic >/= 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an effective method of birth-control while receiving study therapy and for six months after completion of therapy.

      11) No prior chest or upper abdomen radiotherapy; prior therapy with cisplatin, docetaxel, panitumumab or other anti-EGFR therapy; or prior esophageal or gastric surgery. (Exception: prior surgery to treat reflux disease)

      12) No 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.

      13) No history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan.

      14) No history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.

      Exclusion Criteria:N/A

      .
      Links
      Registration Number: NCT00757172
      Study Information on Clinical Trials Registry (clinicaltrials.gov)

      Other Links:
      .
      Results


      Return to Clinical Trials at M.D. Anderson Cancer Center