Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT00183872
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 14, 2005
Status verified
Dec 2017
Primary completion
Oct 20, 2014
Completion
Oct 20, 2015

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Irinotecan and Docetaxel
    Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days

Primary Outcome Measure

Objective Response (Complete, Partial, Stable and Progression) [ Time Frame: every 2 cycles ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern California (U.S.C.)/ Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

Find similar trials in Los Angeles, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center· Los Angeles, CA

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