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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00757172
Other study ID # ACOSOG-Z4051
Secondary ID ACOSOG-Z4051CDR0
Status Completed
Phase Phase 2
First received September 22, 2008
Last updated February 10, 2016
Start date January 2009
Est. completion date December 2014

Study information

Verified date February 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 2014
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
panitumumab

Drug:
cisplatin

docetaxel

Procedure:
neoadjuvant therapy

therapeutic conventional surgery

Radiation:
radiation therapy


Locations

Country Name City State
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina
United States Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
United States Good Samaritan Hospital Dayton Ohio
United States Evanston Hospital Evanston Illinois
United States Wayne Hospital Greenville Ohio
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Central Baptist Hospital Lexington Kentucky
United States Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania
United States UPMC Cancer Centers Pittsburgh Pennsylvania
United States Legacy Emanuel Hospital and Health Center and Children's Hospital Portland Oregon
United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon
United States Mayo Clinic Cancer Center Rochester Minnesota
United States William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia
United States Simmons Cooper Cancer Institute Springfield Illinois
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology Amgen, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 t — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Pathologic Complete Response Following Surgery 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. Post surgery No
Secondary Number of Participants With Near-complete Response Rate (= 10% Residual Cancer in Primary Tumor Viable) Post surgery No
Secondary Percentage of Participants With 3-year Overall Survival 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). 3 years No
Secondary Percentage of Participants With 2-year Disease-free Survival 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. 2 years No
Secondary Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution 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. Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery Yes
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