Status:
COMPLETED
Combination Chemotherapy and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of capecitabine when administered with carboplatin, paclitaxel, and radiotherapy in patients with carcinoma o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed carcinoma of the thoracic esophagus or gastroesophageal junction for which bimodality treatment with chemotherapy and radiotherapy is indicated
- No tumors that extend above the level of the thoracic inlet or beyond 4 cm below the gastroesophageal junction
- No esophageal perforation based on radiographic or bronchoscopic evidence
- No known brain metastases, lymphangitic lung metastases, or carcinomatous meningitis
- PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 70%
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- AST or ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 mg/dL
- Creatinine ≤ 1.5 times ULN
- Calcium ≤ 1.3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection or other serious underlying medical condition that would preclude study treatment
- No dementia or significantly altered mental status that would preclude understanding or giving informed consent
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No other concurrent investigational therapy
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00281788
Start Date
September 1 2003
End Date
July 1 2007
Last Update
March 21 2013
Active Locations (1)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710