Irinotecan, Radiation Therapy, and Docetaxel With or Without Cisplatin in Treating Patients With Locally Advanced Esophageal Cancer
Completed · Phase 1
Conditions studied: Esophageal Cancer
In brief
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan and docetaxel may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with irinotecan and radiation therapy with or without cisplatin in treating patients with locally advanced esophageal cancer.
Key facts
- Study ID
- NCT00601692
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 27
- Starts
- 2003-04-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2013-03-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed squamous cell carcinoma, adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of the esophagus or gastroesophageal (GE) junction
- Disease clinically limited to the esophagus or GE junction (T1, N1, M0, or T2-4, any N, M0)
- M1a metastatic disease to lymph nodes allowed
- Includes celiac lymph nodes in a patient with a distal third esophageal primary lesion or a gastroesophageal junction primary or supraclavicular lymph nodes in a patient with a proximal third esophageal lesion
- Disease must be able to be contained in a radiotherapy field
- Previously untreated patients with primary tumors of the cervical or thoracic esophagus, including the GE junction, are eligible for this study
- At least 50% of the tumor must involve the distal esophagus for tumors of the GE junction
You may not qualify if…
- Positive malignant cytology of the pleura, pericardium, or peritoneum
- Metastatic disease to distant organs (e.g. liver) or non-regional lymph nodes
- Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- Karnofsky performance status (PS) 70-100% OR ECOG PS 0-2
- ANC ≥ 1,500 cells/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 mg/dL
- Creatinine ≤ 1.5 mg/dL
- Total serum bilirubin ≤ 1.0 mg/dL
- AST ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Men and women of child bearing potential must use effective contraception while on treatment and for a reasonable period thereafter
- Negative pregnancy test
- Exclusion criteria:
- History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- Pre-existing peripheral neuropathy > grade 1
- Severe comorbid conditions including, but not limited to, any of the following:
- NYHA class III-IV cardiac disease
- Myocardial infarction within the past 6 months
- Severe uncontrolled diabetes
- Hypercalcemia
- Uncontrolled hypertension
- Cerebral vascular disease
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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