search
Back to results

Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

Primary Purpose

Esophageal Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
gefitinib
irinotecan hydrochloride
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma (AC) or squamous cell carcinoma of the esophagus AC of the gastroesophageal junction allowed Tumor must be considered surgically resectable (T1-3, NX) No early-stage cancer (T1, N0) The following lymph node (LN) criteria are considered acceptable: Regional thoracic LN metastases (N1) LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by CT scan No distant metastases (M0) PATIENT CHARACTERISTICS: Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Creatinine clearance ≥ 50 mL/min Creatinine serum level ≤ CTC grade 2 Bilirubin ≤ 2 times upper limit of normal (ULN) AST < 3 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No known severe hypersensitivity to gefitinib or any of its excipients No evidence (except asymptomatic chronic stable radiographic changes) of clinically active interstitial lung disease No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable angina No New York Heart Association class III or IV heart disease No other concurrent malignancies or malignancies diagnosed within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix No serious active or uncontrolled infection, systemic disease, psychiatric illness, or other medical condition that would preclude study participation No evidence of any significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for esophageal cancer No prior radiotherapy that would overlap the study treatment fields Recovered from prior major surgery No nonapproved or investigational drugs within the past 30 days No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Pathological response (complete and partial) post-operatively

Secondary Outcome Measures

Safety and toxicity post-operatively
Response rate 2 weeks into treatment, pre-operatively, and post-operatively
Completeness of resection post-operatively
Surgical morbidity and mortality post-operatively
Compare the effects of gefitinib on biomarkers that effect EGF signaling and genomic composition of tumor samples before and after treatment

Full Information

First Posted
February 9, 2006
Last Updated
May 7, 2014
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00290719
Brief Title
Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
Official Title
A Phase I/II Study to Evaluate Safety and Efficacy in Patients Who Have Resectable Esophageal Cancer and Are Treated With Neoadjuvant Cisplatin, Irinotecan (CPT-11) ZD1839 (IRESSA), and Radiotherapy Followed by Surgical Resection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with chemotherapy 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 I/II trial is studying the side effects of gefitinib when given together with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they work in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.
Detailed Description
OBJECTIVES: Primary Evaluate the pathologic response (complete and partial) in patients with resectable esophageal or gastroesophageal junction cancer treated with neoadjuvant gefitinib, cisplatin, irinotecan hydrochloride, and radiotherapy followed by surgical resection. Secondary Assess the safety and toxicity of this regimen in these patients. Evaluate objective tumor response in patients treated with this regimen. Determine the rate of complete resection in patients treated with this regimen. Determine surgical morbidity and mortality in patients treated with this regimen. OUTLINE: This is an open-label study. Induction phase: Patients receive oral gefitinib once daily on days 1-14. Patients with stable or responding disease proceed to neoadjuvant chemoradiotherapy. Neoadjuvant chemoradiotherapy: Patients receive gefitinib as in the induction phase beginning in week 4 and continuing through the last day of radiotherapy. Patients also receive cisplatin IV over 1 hour and irinotecan hydrochloride IV over 30 minutes on days 22, 29, 43, and 50 and undergo radiotherapy once daily, 5 days a week, for 5 weeks (total of 25 doses). Surgery: Within 4-8 weeks after completion of neoadjuvant chemoradiotherapy, patients with stable or responding disease undergo an esophagectomy and lymph node dissection. Patients with a progressive or unresectable disease are removed from the study. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Pathological response (complete and partial) post-operatively
Secondary Outcome Measure Information:
Title
Safety and toxicity post-operatively
Title
Response rate 2 weeks into treatment, pre-operatively, and post-operatively
Title
Completeness of resection post-operatively
Title
Surgical morbidity and mortality post-operatively
Title
Compare the effects of gefitinib on biomarkers that effect EGF signaling and genomic composition of tumor samples before and after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma (AC) or squamous cell carcinoma of the esophagus AC of the gastroesophageal junction allowed Tumor must be considered surgically resectable (T1-3, NX) No early-stage cancer (T1, N0) The following lymph node (LN) criteria are considered acceptable: Regional thoracic LN metastases (N1) LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by CT scan No distant metastases (M0) PATIENT CHARACTERISTICS: Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Creatinine clearance ≥ 50 mL/min Creatinine serum level ≤ CTC grade 2 Bilirubin ≤ 2 times upper limit of normal (ULN) AST < 3 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No known severe hypersensitivity to gefitinib or any of its excipients No evidence (except asymptomatic chronic stable radiographic changes) of clinically active interstitial lung disease No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable angina No New York Heart Association class III or IV heart disease No other concurrent malignancies or malignancies diagnosed within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix No serious active or uncontrolled infection, systemic disease, psychiatric illness, or other medical condition that would preclude study participation No evidence of any significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for esophageal cancer No prior radiotherapy that would overlap the study treatment fields Recovered from prior major surgery No nonapproved or investigational drugs within the past 30 days No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Ko, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

We'll reach out to this number within 24 hrs