NCT00005638

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4.5 years

First QC Date

May 2, 2000

Last Update Submit

June 17, 2013

Conditions

Esophageal CancerGastric Cancer

Keywords

stage II gastric cancerstage III gastric cancerstage II esophageal cancerstage III esophageal canceradenocarcinoma of the stomachsquamous cell carcinoma of the esophagusadenocarcinoma of the esophagus

Interventions

cisplatinDRUG
irinotecan hydrochlorideDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Ilson 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: 12885811RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsEsophageal Squamous Cell CarcinomaAdenocarcinoma Of Esophagus

Interventions

CisplatinIrinotecanRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic CompoundsTherapeutics

Study Officials

  • David H. Ilson, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

October 1, 1999

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(2)