Clinical trial · Interventional
Irinotecan, Radiation Therapy, and Docetaxel With or Without Cisplatin in Treating Patients With Locally Advanced Esophageal Cancer
A Phase I Trial of Irinotecan, Radiation Therapy and Escalating Doses of Docetaxel With Cisplatin in Locally Advanced Esophageal Cancer
NCT00601692CI-TRIAL-00009795completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen 1
- description
- Patients receive docetaxel IV over 15 minutes and irinotecan hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 8, patients receive docetaxel IV over 15 minutes and irinotecan hydrochloride IV over 30 minutes on days 1 (week 8) and 8 (week 9). Patients also undergo radiotherapy once daily, 5 days a week, in weeks 8-10. Treatment with chemoradiotherapy repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: docetaxel
- Drug: irinotecan hydrochloride
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Regimen 2
- description
- Patients receive docetaxel IV and irinotecan hydrochloride as in regimen 1 induction chemotherapy. They also receive cisplatin IV over 20-30 minutes on days 1 and 8. Treatment with irinotecan hydrochloride, docetaxel, and cisplatin repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients receive docetaxel IV, irinotecan hydrochloride IV, and undergo radiotherapy as in regimen 1 chemoradiotherapy. Patients also receive cisplatin IV over 20-30 minutes on days 1 (week 8) and 8 (week 9). Treatment with irinotecan hydrochloride, docetaxel, cisplatin, and radiotherapy repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
Inclusion criteria:
* 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
Exclusion criteria:
* 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
* Uncontrolled infections
* Pregnant or lactating women
* History of prior malignancy diagnosed and/or treated within the past three years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder
* Known Gilbert disease
* History of seizure disorder with concurrent phenytoin, phenobarbital, or other antiepileptic medication
* Any other concurrent medical or psychiatric condition or disease that, in the investigator's judgment, would make the patient inappropriate for entry into this study
* Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy (RT) for this esophageal cancer
* No prior mantle RT, chest RT, pelvic RT, or hemi-body RTReferences
Publications (0)
Data not yet available
No reference posted for this study.