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 is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Amgen
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00757172
First received: September 22, 2008
Last updated: August 14, 2014
Last verified: August 2014
  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: Intervention Model: Single Group Assignment
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Number of Participants With Pathologic Complete Response Following Surgery [ Time Frame: Post surgery ] [ Designated as safety issue: No ]
    Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.


Secondary Outcome Measures:
  • Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable) [ Time Frame: Post surgery ] [ Designated as safety issue: No ]
  • Percentage of Participants With 3-year Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).

  • Percentage of Participants With 2-year Disease-free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.

  • Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution [ Time Frame: Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery ] [ Designated as safety issue: Yes ]
    Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.


Enrollment: 70
Study Start Date: January 2009
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Docetaxel + Cisplatin + Panitumumab + RT
Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Biological: panitumumab Drug: cisplatin Drug: docetaxel Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: radiation therapy

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
  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 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 of T3N0M0, T2-3N1M0 or T2-3N0-1M1a (celiac adenopathy must be ≤ 2 cm by EUS). Clinically staged T1 tumors 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 (CTCAE v3) of any etiology.
  7. Adequate bone marrow, hepatic and renal function prior to registration:

    • 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 (SGOT) ≤ 2.0 times upper limit of normal (ULN)
    • ALT (SGPT) ≤ 2.0 times ULN
    • Alkaline phosphatase ≤ 2.0 times ULN
    • Albumin ≥ 2.0 g/dL OR prealbumin ≥ 15 mg/dL
    • Magnesium ≥ lower limit of normal (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 prior to registration (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 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 psyschiatric illness/social situations that would limit compliance with study requirements.
  13. No history of interstitial lung disease (eg, 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.
  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
Alliance for Clinical Trials in Oncology
Amgen
Investigators
Study Chair: A. Craig Lockhart, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00757172     History of Changes
Other Study ID Numbers: CDR0000596674, ACOSOG-Z4051, CDR0000596674, NCI-2009-00346, U10CA076001
Study First Received: September 22, 2008
Results First Received: July 25, 2014
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
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
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014