Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT00020761
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • irinotecan hydrochloride — DRUG
    The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.
  • paclitaxel — DRUG
    The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.

Study Details

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.

Key Dates

Start date
Apr 30, 2000
Status verified
Jul 2012
Primary completion
Dec 31, 2002
Completion
Aug 31, 2005

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gastro Esophogeal cohort
    Patients with adenocarcinoma of the esophagus, gastroesophageal (GE) junction and gastric cardia (GE cohort) The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks. Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.
  • Experimental: Distal Stomach cohort
    Patients with adenocarcinoma of the rest of the stomach (Distal Stomach cohort) The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met. Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks. Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.

Primary Outcome Measure

To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia. [ Time Frame: 5 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Jonsson Comprehensive Cancer Center, UCLALos AngelesCalifornia90095-1781-
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90033-0804-
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicagoIllinois60611-3013-
OHSU Cancer InstitutePortlandOregon97201-3098-

Find similar trials in Los Angeles, CA

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Jonsson Comprehensive Cancer Center, UCLA· Los Angeles, CAUSC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CARobert H. Lurie Comprehensive Cancer Center, Northwestern University· Chicago, ILOHSU Cancer Institute· Portland, OR

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