Phase 2 N=65 Treatment

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

Adenocarcinoma of the Gastroesophageal Junction · Esophageal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00757172 ↗

Enrolled (actual)

Serious AEs

65.7%

Results posted

Aug 2014

Primary outcome: Primary: Number of Participants With Pathologic Complete Response Following Surgery — 18 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: panitumumab (Biological); cisplatin (Drug); docetaxel (Drug); neoadjuvant therapy (Procedure); therapeutic conventional surgery (Procedure); radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Pathologic Complete Response Following Surgery	18	—
SECONDARY Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)	11	—
SECONDARY Percentage of Participants With 3-year Overall Survival	38.6	—
SECONDARY Percentage of Participants With 2-year Disease-free Survival	41.4	—
SECONDARY Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution	12; 30; 12; 13; 13; 11	—

Summary

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.

Eligibility Criteria

≥ 18 years old
ECOG/Zubrod Performance Status 0-1
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
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.
No definitive radiological evidence of distant metastases.
No pre-existing grade 2 or greater peripheral neuropathy (CTCAE v3) of any etiology.
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)
Patient must be evaluated before registration by medical oncologist, radiation oncologist and surgeon and deemed fit for protocol therapy and surgery.
No prior invasive malignancy, unless disease-free for ≥ 5 years prior to registration (Exceptions: non-melanoma skin cancer, in-situ cancers).
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.
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)
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.
No history of interstitial lung disease (eg, 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00757172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.