Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00757172
First received: September 22, 2008
Last updated: June 6, 2012
Last verified: July 2011
  Purpose

RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with panitumumab and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel, cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed, locally advanced esophageal cancer or cancer of the gastroesophageal junction.


Condition Intervention Phase
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Biological: panitumumab
Drug: cisplatin
Drug: docetaxel
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete pathologic tumor response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Near-complete response rate (≤ 10% residual cancer in primary tumor viable) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 69
Study Start Date: January 2009
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the pathologic complete response rate in patients with newly diagnosed, locally advanced adenocarcinoma of the distal esophagus or gastroesophageal junction treated with neoadjuvant panitumumab and combination chemoradiotherapy followed by surgery.

Secondary

  • To determine the near-complete pathologic response rate in the primary tumor (≤ 10% residual viable cancer).
  • To determine the overall survival and disease-free survival rates of these patients.
  • To determine the safety profile of this regimen.

OUTLINE: Patients receive panitumumab IV over 1 hour, docetaxel IV over 1 hour, and cisplatin IV over 1-2 hours on day 1 in weeks 1, 3, 5, 7, and 9. Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 6-9 weeks after completion of chemoradiotherapy, patients with no evidence of metastatic disease undergo esophagectomy.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year OR every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Biopsy-proven adenocarcinoma of the distal esophagus or gastroesophageal junction, meeting all of the following criteria:

    • Siewert type I or II disease
    • Newly diagnosed disease (nonrecurrent)
    • Resectable disease
  • Clinical stage T1-3,N1,M0; T3,N0,M0; or T1-3,N0-1,M1a (celiac adenopathy must be ≤ 2 cm by esophageal ultrasound) disease

    • No T1 tumors or T2,N0,M0 tumors allowed
  • Locally advanced disease

    • No definitive radiological evidence of distant metastases

PATIENT CHARACTERISTICS:

  • ECOG/Zubrod performance status 0-1
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.5 g/dL
  • Creatinine ≤ 1.5 mg/dL
  • Total bilirubin ≤ 3 mg/dL
  • AST and ALT ≤ 2.0 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.0 times ULN
  • Albumin ≥ 2.0 g/dL OR prealbumin ≥ 15 mg/dL
  • Magnesium ≥ lower limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No pre-existing peripheral neuropathy of any etiology ≥ grade 2 (CTCAE V3)
  • No prior invasive malignancy, unless disease-free for ≥ 5 years before registration, except for nonmelanoma skin cancer or in situ cancers
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would limit compliance with study requirements
  • No history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or any evidence of interstitial lung disease on baseline chest CT scan
  • 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

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to chest or upper abdomen
  • No prior cisplatin, docetaxel, panitumumab, or other anti-EGFR therapy
  • No prior esophageal or gastric surgery

    • Prior surgery to treat reflux disease allowed
  • No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
  • No concurrent investigational agents
  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: NCT00757172

Locations
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Simmons Cooper Cancer Institute
Springfield, Illinois, United States, 62794-9677
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
United States, Michigan
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
United States, Oregon
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Carolyn E. Reed, MD Medical University of South Carolina
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David M. Ota, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier: NCT00757172     History of Changes
Other Study ID Numbers: CDR0000596674, ACOSOG-Z4051
Study First Received: September 22, 2008
Last Updated: June 6, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus
adenocarcinoma of the gastroesophageal junction
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014