Status:
TERMINATED
Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00290719
Start Date
November 1 2005
End Date
June 1 2008
Last Update
May 9 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115