NCT00601692

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

April 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

6.7 years

First QC Date

January 17, 2008

Last Update Submit

March 21, 2013

Conditions

Esophageal Cancer

Keywords

squamous cell carcinoma of the esophagusadenocarcinoma of the esophagusstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of docetaxel when administered together with irinotecan hydrochloride and radiotherapy

    2 years

Secondary Outcomes (1)

  • Clinical and pathological complete response rate

    2 years

Study Arms (2)

Regimen 1

EXPERIMENTAL

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.

Drug: docetaxelDrug: irinotecan hydrochlorideRadiation: radiation therapy

Regimen 2

EXPERIMENTAL

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.

Drug: cisplatinDrug: docetaxelDrug: irinotecan hydrochlorideRadiation: radiation therapy

Interventions

cisplatinDRUG

Given IV

Regimen 2
docetaxelDRUG

Given IV

Regimen 1Regimen 2
irinotecan hydrochlorideDRUG

Given IV

Regimen 1Regimen 2
radiation therapyRADIATION

Given 5 days a week for 3 weeks

Regimen 1Regimen 2

Eligibility Criteria

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

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:
  • 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
  • History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAdenocarcinoma Of Esophagus

Interventions

CisplatinDocetaxelIrinotecanRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic CompoundsTherapeutics

Study Officials

  • David H. Ilson, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 28, 2008

Study Start

April 1, 2003

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

US(1)