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.
OBJECTIVES: Primary * Determine the response rate in patients with carcinoma of unknown primary when treated with gemcitabine and irinotecan. * Determine the adverse event profile and tolerability of this regimen, based on the presence or absence of the UGT1A1\*28 polymorphism, in these patients. (Cohort I closed to accrual 11/17/05) * Determine the adverse event profile and tolerability of this regimen. (Cohort II) Secondary * Determine the time to progression and overall survival of patients treated with this regimen. * Correlate patterns of immunohistochemical staining with response in patients treated with this regimen. * Correlate variation in multiple different genes, whose protein products are involved in the uptake, metabolism, and distribution of these drugs, with clinical outcomes, in terms of response and toxicity, in these patients. * Determine primary origin of cancer of unknown primary samples by completing a 92-gene RT-PCR cancer classification assay. * Determine whether the 92-gene assay results are correlated with clinical response to gemcitabine and irinotecan. OUTLINE: * 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. * 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. Patients are followed every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Given IV
Given IV
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria
The primary endpoint is confirmed response rate. If measurable disease is present, a confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All registered patients meeting the eligibility criteria that have signed a consent form and have begun treatment will be evaluable for response.
Time frame: Up to 2 years
Overall Survival
Overall survival time is defined as the time from registration to death due\> to any cause. The distribution of survival time will be estimated using\> the method of Kaplan-Meier . Overall survival will be calculated for\> all evaluable patients combined and by group (ie. for patients with or\> without the UGT1A1\*28 polymorphism).
Time frame: Up to 2 years
Time to Disease Progression
Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Time to disease progression will be calculated for all evaluable patients combined and by group (ie. for patients with or without the UGT1A1\*28 polymorphism).
Time frame: Up to 2 years
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