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Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
This study is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020761
  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 combining irinotecan and paclitaxel in treating patients who have metastatic or recurrent cancer of the esophagus or stomach.


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

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract

Resource links provided by NLM:


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

Study Start Date: April 2000
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of irinotecan and paclitaxel in patients with metastatic or recurrent adenocarcinoma of the esophagus or stomach.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia vs adenocarcinoma of the rest of the stomach).

Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 26-54 patients (13-27 per stratum) 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 adenocarcinoma of the esophagus (including the gastroesophageal junction) or stomach

    • Inoperable metastatic or recurrent disease
    • Incurable with chemotherapy, radiotherapy, surgery, or combination therapy
  • Bidimensionally measurable disease

    • At least 1 cm x 1 cm by CT scan or MRI
    • Mediastinal or hilar lymph nodes at least 2 cm in longest dimension by CT scan or MRI
    • No prior radiotherapy to only evaluable lesion
  • No brain metastases
  • No osseous metastasis as only site of disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 3 times upper limit of normal
  • No known Gilbert's syndrome

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No uncontrolled, clinically evident congestive heart failure

Other:

  • No history of seizures
  • No serious infection
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other disease that would preclude study
  • No psychiatric disorders that would preclude study compliance
  • No significant clinical neuropathy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • No more than 1 prior immunotherapy regimen for metastatic disease
  • No concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No prior paclitaxel or irinotecan
  • No more than 1 prior chemotherapy regimen for metastatic disease except fluorouracil as an adjuvant or radiosensitizer
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior limited radiotherapy and recovered
  • No prior radiotherapy to major bone marrow-containing areas (pelvis or lumbar spine)
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 1 week since prior minor surgery
  • At least 3 weeks since prior major surgery
  • Recovered from prior surgery

Other:

  • At least 4 weeks since prior investigational therapy
  • No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
  • No other concurrent medication except analgesics, chronic treatments for concurrent medical conditions, or agents required for life-threatening medical problems
  • No concurrent prochlorperazine on day of irinotecan administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020761

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Oregon
OHSU Cancer Institute
Portland, Oregon, United States, 97201-3098
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Joel R. Hecht, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068711, UCLA-0001048, NCI-G01-1957
Study First Received: July 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00020761     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
adenocarcinoma of the esophagus

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Irinotecan
Esophageal Cancer
Antimitotic Agents
Camptothecin
Recurrence
Carcinoma
Digestive System Diseases
Stomach Diseases
Paclitaxel
Esophageal Disorder
Stomach Neoplasms
Head and Neck Neoplasms
Tubulin Modulators
Gastrointestinal Neoplasms
Stomach Cancer
Esophageal Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Irinotecan
Neoplasms by Site
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Camptothecin
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Paclitaxel
Head and Neck Neoplasms
Tubulin Modulators
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009