Clinical trial · Interventional

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer

NCT00005638CI-TRIAL-00010844completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have advanced cancer of the esophagus.

Conditions

Conditions (2)

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
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
cisplatin	Drug	Cisplatin	ALIAS
irinotecan hydrochloride	Drug	Irinotecan	ALIAS
radiation therapy	Radiation	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction

  * T1, N1, M0 or T2-4, Nx, M0

    * No supraclavicular or celiac lymph nodes
* Previously untreated, newly diagnosed tumors OR
* Prior resection without adjuvant therapy with local regional failure

  * Positive microscopic margin on resection of all gross disease allowed provided no metastatic disease
* No positive malignant cytology of the pleura, pericardium, or peritoneum
* No biopsy proven tumor invasion of the tracheobronchial tree or tracheoesophageal fistula

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100% OR
* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* No known Gilbert's disease

Renal:

* Creatinine no greater than 1.5 mg/dL
* No hypercalcemia

Cardiovascular:

* No New York Heart Association class III or IV heart disease
* No myocardial infarction within the past 6 months
* No uncontrolled hypertension

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other severe concurrent conditions (e.g., severe uncontrolled diabetes, uncontrolled infections, or cerebral vascular disease)
* No other malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
* No history of seizure disorder currently receiving phenytoin, phenobarbital, or other antiepileptic medication
* No other concurrent medical or psychiatric condition or disease that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for esophageal cancer including adjuvant chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy for esophageal cancer including adjuvant radiotherapy
* No prior mantle, chest, pelvic, or hemibody radiotherapy

Surgery:

* See Disease Characteristics

Other:

* No concurrent prochlorperazine on day of irinotecan administration

References

Publications (1)

RESULTIlson DH, Bains M, Kelsen DP, O'Reilly E, Karpeh M, Coit D, Rusch V, Gonen M, Wilson K, Minsky BD. Phase I trial of escalating-dose irinotecan given weekly with cisplatin and concurrent radiotherapy in locally advanced esophageal cancer. J Clin Oncol. 2003 Aug 1;21(15):2926-32. doi: 10.1200/JCO.2003.02.147. PMID 12885811

Registry

Dates and enrollment

Start: Oct 1, 1999
Primary completion: Apr 1, 2004
Completion: Apr 1, 2004
First posted: Jan 27, 2003
Last update posted: Jun 19, 2013
Lead sponsor: Memorial Sloan Kettering Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: stage II gastric cancer, stage III gastric cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the stomach, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus

Data updated 22 days agoSource updated Jun 19, 2013source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United States	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.