Trial record 1 of 1 for:    ACOSOG Z4051
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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

September 22, 2008
June 6, 2012
January 2009
November 2011   (final data collection date for primary outcome measure)
Complete pathologic tumor response [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00757172 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction
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

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer
  • Biological: panitumumab
  • Drug: cisplatin
  • Drug: docetaxel
  • Procedure: neoadjuvant therapy
  • Procedure: therapeutic conventional surgery
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
Not Provided
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00757172
CDR0000596674, ACOSOG-Z4051
Not Provided
David M. Ota, American College of Surgeons Oncology Group
American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Carolyn E. Reed, MD Medical University of South Carolina
National Cancer Institute (NCI)
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP