A Phase II Study Of Gemcitabine (GEMZAR) And Irinotecan (CPT-11) In Previously Untreated Patients With Measurable Disease With Unknown Primary Carcinoma
- 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)
- Determine the time to progression and overall survival of patients treated with this
- 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.
- 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.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Confirmed response rate (partial or complete response for 2 consecutive evaluations at least 4 weeks apart) as measured by RECIST criteria
Matthew P. Goetz, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|Mercy Cancer Center at Mercy Medical Center - North Iowa||Mason City, Iowa 50401|
|Cancer Resource Center - Lincoln||Lincoln, Nebraska 68510|