Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary

Part of paid clinical trials in Mason City, Iowa.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00066781
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma of Unknown Primary

Eligibility Criteria

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

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan 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: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with cancer of unknown primary origin.

Key Dates

Start date
Feb 29, 2004
Status verified
Feb 2017
Primary completion
Apr 30, 2008
Completion
Mar 31, 2009

Study Design

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

Arms

  • Experimental: Cohort I (closed to accrual 11/17/05)
    Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort II
    Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria [ Time Frame: Up to 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mercy Cancer Center at Mercy Medical Center - North IowaMason CityIowa50401-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
Cancer Resource Center - LincolnLincolnNebraska68510-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68106-

Find similar trials in Mason City, IA

By research site
Mercy Cancer Center at Mercy Medical Center - North Iowa· Mason City, IAMayo Clinic Cancer Center· Rochester, MNCancer Resource Center - Lincoln· Lincoln, NECCOP - Missouri Valley Cancer Consortium· Omaha, NE

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