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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.
First Received: March 3, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00012363
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012363

  Show 96 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Stephen K. Williamson, MD University of Kansas
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068515, SWOG-S0101
Study First Received: March 3, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00012363     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV gastric cancer
recurrent gastric cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Physiological Effects of Drugs
Irinotecan
Stomach Diseases
Neoplasms by Site
Stomach Neoplasms
Therapeutic Uses
Gemcitabine
Digestive System Neoplasms
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Camptothecin
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009