CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
irinotecan, docetaxeldrug
Likely dose
Docetaxel 30 mg/m² IV on days 1 and 8; irinotecan 65 mg/m² IV on days 1 and 8AI-extracted
Key inclusion· 8
  • ✓Clinically documented unresectable or metastatic gastric or gastroesophageal adenocarcinoma with histologic confirmation
  • ✓One prior chemotherapy regimen for metastatic or unresectable disease
  • ✓No prior irinotecan or taxane therapy
  • ✓Tissue from tumor available (paraffin-embedded from prior biopsy/resection or repeat biopsy)
Key exclusion· 7
  • ✕History of allergy to irinotecan
  • ✕Active or uncontrolled infection, including HIV
  • ✕Myocardial infarction within 6 months or congestive heart failure requiring therapy
  • ✕Clinically apparent CNS metastases or carcinomatous meningitis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00183872
NCT00183872Phase 2Completed
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Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

University of Southern California·interventional·Posted Sep 16, 2005·Updated Feb 19, 2018

In Brief

A Phase 2 clinical trial evaluating irinotecan, docetaxel for Gastric Cancer and Esophageal Neoplasms. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after receiving treatment with the drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere). Irinotecan is a drug that has been approved by the Food and Drug Administration (FDA). Irinotecan has been approved for treatment of cancer of the colon and rectum. Docetaxel is another drug approved by the FDA. Docetaxel is approved for treatment of breast, prostate and lung cancer. However, the FDA has authorized the use of irinotecan and docetaxel in this study. This study will evaluate the effects of these drugs on participant's tumors. The side effects of the combination of irinotecan and docetaxel will also be evaluated. This study will also measure the levels of certain substances in participant's tumors. These substances, called genes (which are the cell's blueprint), affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. The researchers want to see if these substances can predict response to the study drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Esophageal Neoplasms
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartApr 14, 2005
Primary CompletionOct 20, 2014
Study CompletionOct 20, 2015
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 20.8 years ago

Interventions

irinotecan, docetaxeldrug

docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.