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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.
Study NCT00020761   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes

July 11, 2001
July 23, 2008
April 2000
 
 
 
Complete list of historical versions of study NCT00020761 on ClinicalTrials.gov Archive Site
 
 
 
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract

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.

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.

Phase II
Interventional
Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • Drug: irinotecan hydrochloride
  • Drug: paclitaxel
 
 

*   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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020761
 
CDR0000068711, UCLA-0001048, NCI-G01-1957
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Joel R. Hecht, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2003

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