Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075738
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007

January 9, 2004
July 23, 2008
October 2003
Not Provided
Objective response rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00075738 on ClinicalTrials.gov Archive Site
  • Clinical benefit [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Local relapse-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer.

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy.

Secondary

  • Determine the clinical benefit in patients treated with this regimen.
  • Determine the tolerability of this regimen in these patients.
  • Determine local relapse-free survival of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 1 year.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
Not Provided
Not Provided

DISEASE CHARACTERISTICS:

  • Histologically confirmed esophageal cancer

    • Metastatic disease
  • At least 1 unidimensionally measurable metastatic lesion

    • At least 10 mm by spiral scanner OR 20 mm by sequential scanner
    • Outside the field of prior radiotherapy
  • No known symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times normal
  • Alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present)
  • SGOT and SGPT ≤ 3 times normal

Renal

  • Creatinine ≤ 1.5 mg/dL

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No uncontrolled angina

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other illness or medical condition that would preclude study participation
  • No psychological, social, familial, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 6 months since prior fluorouracil and/or cisplatin
  • No other prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 6 weeks since prior radiotherapy

Surgery

  • More than 4 weeks since prior surgery

Other

  • No concurrent participation in another clinical study
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00075738
CDR0000349275, FRE-GERCOR-D00-2, EU-20328
Not Provided
Not Provided
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Not Provided
Investigator: Pascal Artru, MD Clinique Saint Jean
National Cancer Institute (NCI)
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP