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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

September 22, 2008
August 14, 2014
January 2009
November 2011   (final data collection date for primary outcome measure)
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.
Complete pathologic tumor response [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00757172 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
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
Intervention Model: Single Group Assignment
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
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).
Interventions:
  • Biological: panitumumab
  • Drug: cisplatin
  • Drug: docetaxel
  • Procedure: neoadjuvant therapy
  • Procedure: therapeutic conventional surgery
  • Radiation: radiation therapy
Lockhart AC, Reed CE, Decker PA, Meyers BF, Ferguson MK, Oeltjen AR, Putnam JB, Cassivi SD, Montero AJ, Schefter TE; American College of Surgeons Oncology Group. Phase II study of neoadjuvant therapy with docetaxel, cisplatin, panitumumab, and radiation therapy followed by surgery in patients with locally advanced adenocarcinoma of the distal esophagus (ACOSOG Z4051). Ann Oncol. 2014 May;25(5):1039-44. doi: 10.1093/annonc/mdu091. Epub 2014 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
Not Provided
November 2011   (final data collection date for primary outcome measure)
  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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00757172
CDR0000596674, ACOSOG-Z4051, CDR0000596674, NCI-2009-00346, U10CA076001
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)
  • Amgen
Study Chair: A. Craig Lockhart, MD Washington University School of Medicine
Alliance for Clinical Trials in Oncology
August 2014

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