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

Sponsors and Collaborators:	American College of Surgeons National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00757172

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 II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Radiation Therapy Surgery

Drug Information available for: Cisplatin Docetaxel Panitumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

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
Estimated Primary Completion Date:	June 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
No prior invasive malignancy, unless disease-free for ≥ 5 years, 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
No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
No concurrent investigational agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757172

Locations

United States, Kentucky
Central Baptist Hospital	Recruiting
Lexington, Kentucky, United States, 40503-9985
Contact: Clinical Trials Office - Central Baptist Hospital 859-260-6425
United States, Oregon
Providence Cancer Center at Providence Portland Medical Center	Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412
United States, Pennsylvania
Allegheny Cancer Center at Allegheny General Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Robert J. Keenan, MD 412-359-6202
St. Luke's Cancer Network at St. Luke's Hospital	Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Darius Desai, MD 610-954-2140
York Cancer Center at Apple Hill Medical Center	Recruiting
York, Pennsylvania, United States, 17405
Contact: Ronald E. Hempling, MD 717-741-8100
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Carolyn E. Reed, MD

Medical University of South Carolina

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	American College of Surgeons Oncology Group ( David M. Ota )
Study ID Numbers:	CDR0000596674, ACOSOG-Z4051
Study First Received:	September 22, 2008
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00757172 History of Changes
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Carcinoma
Docetaxel
Digestive System Diseases
Radiation-Sensitizing Agents

Cisplatin
Esophageal Disorder
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms

Digestive System Diseases
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009