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Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
This study is ongoing, but not recruiting participants.
Study NCT00012363   Information provided by National Cancer Institute (NCI)
First Received: March 3, 2001   Last Updated: July 23, 2008   History of Changes

March 3, 2001
July 23, 2008
April 2001
 
 
 
Complete list of historical versions of study NCT00012363 on ClinicalTrials.gov Archive Site
 
 
 
Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent cancer of the esophagus.

OBJECTIVES:

  • Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.

Phase II
Interventional
Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: irinotecan hydrochloride
 
Williamson SK, McCoy SA, Gandara DR, Dakhil SR, Yost KJ, Paradelo JC, Atkins JN, Blanke CD, Abbruzzese JL; Southwest Oncology Group (SWOG). Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) trial. Am J Clin Oncol. 2006 Apr;29(2):116-22.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction

    • Squamous cell carcinoma OR
    • Adenocarcinoma
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 to 100

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 1.5 times upper limit of normal

Cardiovascular:

  • No uncontrolled hypertension
  • No unstable angina
  • No symptomatic congestive heart failure
  • No myocardial infarction within the past 6 months
  • No serious uncontrolled cardiac arrhythmia

Gastrointestinal:

  • No active inflammatory bowel disease
  • No significant bowel obstruction
  • No chronic diarrhea

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active infection requiring systemic therapy
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 28 days since prior biologic therapy
  • No prior biologic therapy for metastatic or recurrent disease
  • No concurrent sargramostim (GM-CSF)
  • No concurrent immunotherapy for tumor

Chemotherapy:

  • At least 28 days since prior chemotherapy
  • No prior chemotherapy for metastatic or recurrent disease
  • No prior gemcitabine or irinotecan
  • Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed
  • No other concurrent chemotherapy for tumor

Endocrine therapy:

  • See Disease Characteristics
  • At least 28 days since prior endocrine therapy
  • No prior endocrine therapy for metastatic or recurrent disease
  • No concurrent hormonal therapy for tumor

Radiotherapy:

  • At least 28 days since prior radiotherapy
  • No prior radiotherapy for metastatic or recurrent disease
  • Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed
  • No concurrent radiotherapy for tumor

Surgery:

  • Prior thoraco-abdominal surgery allowed
  • At least 3 weeks since prior surgery and recovered

Other:

  • No other concurrent anti-cancer therapy for tumor
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012363
 
CDR0000068515, SWOG-S0101
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Stephen K. Williamson, MD University of Kansas
National Cancer Institute (NCI)
May 2002

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