Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary

Phase 2 Completed 31 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2004-02
Primary completion: 2008-04
Completion: 2009-03

Outcome

Missed primary endpoint

paper The confirmed response rate including patients from both cohorts was 12% (95% CI: 2-30%), which did not meet the criteria for continued enrollment. PMID 22815703 ↗

Publications

Results Holtan SG, Foster NR, Erlichman CE, et al.: Gemcitabine (G) and irinotecan (CPT-11) as first-line therapy for carcinoma (ca) of unknown primary (CUP): An NCCTG phase II trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-13525, 2008.
Holtan SG, Steen PD, Foster NR, Erlichman C, Medeiros F, Ames MM, Safgren SL, Graham DL, Behrens RJ, Goetz MP. Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial. PLoS One. 2012;7(7):e39285. doi: 10.1371/journal.pone.0039285. Epub 2012 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	750 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	75 mg/m2	Intravenous