Irinotecan and Alisertib in Treating Patients With Advanced Solid Tumors or Colorectal Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT01923337
Phase
PHASE1
Status
Completed

Conditions

  • Mucinous Adenocarcinoma of the Colon
  • Mucinous Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Signet Ring Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage IIIA Colon Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

Study Details

This phase I trial studies the side effects and best dose of alisertib when given together with irinotecan hydrochloride in treating patients with advanced solid tumors or colorectal cancer. Irinotecan hydrochloride and alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Aug 31, 2013
Status verified
Jan 2019
Primary completion
Oct 17, 2016
Completion
Oct 17, 2016

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (irinotecan, alisertib)
    Patients receive irinotecan hydrochloride IV over 30 minutes on days 1 and 8 and alisertib PO BID on days 1-3 and 8-10. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD, defined as the highest dose tested in which fewer than 33% of patients experience dose-limiting toxicity (DLT) attributable to the study drugs, graded using the National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: Up to day 21 ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-

Find similar trials in Sacramento, CA

By research site
UC Davis Comprehensive Cancer Center· Sacramento, CA

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