Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer

NCT00504153 | Completed Phase 2 Results

• 7 other identifiers: NCI-2009-00223UCCRC-NCI-7786CDR000055703615431A7786N01CM62201P30CA014599
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying dasatinib to see how well it works in treating patients with previously treated metastatic colorectal cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

Conditions

Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate

  Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Patients who are still alive and have not progressed will be censored at the date of the last negative examination. A Simon (1989), optimal, two-stage design will be employed. The progression-free survival count will be the proportion of subjects who are alive and progression-free at 4 months.

  From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.)

Secondary Outcomes (4)

• Response Rate (RR) (Complete or Partial Responders)

  Every 2 courses, assessed up to 8 weeks after completion of study treatment (i.e., up to 10 months)

• Incidence of Somatic Mutations

  1 year

• Association Between the Incidence of Total C-src and Phosphorylated C-src Expression and Response

  4 months

• Change in Plasma Vascular Endothelial Growth Factor (VEGF) Levels Over 15 Days

  At baseline and day 15

Study Arms (1)

Treatment (tyrosine Kinase Inhibitor)

EXPERIMENTAL

Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: dasatinib; Other: laboratory biomarker analysis

Interventions

dasatinib DRUG

Also known as: BMS-354825, Sprycel

Treatment (tyrosine Kinase Inhibitor)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (tyrosine Kinase Inhibitor)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed colorectal cancer
• Metastatic disease
• Not curable by surgical resection
• Archival tumor tissue available
• Measurable disease, defined as at least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Measurable disease must be outside of a prior radiation port
• Documented disease progression either during or after prior chemotherapy treatment
• No more than 2 prior chemotherapy regimens in the adjuvant or metastatic setting
• Prior chemotherapy regimens must have contained a fluoropyrimidine (e.g., fluorouracil or capecitabine), oxaliplatin, and irinotecan
• Patients who received no prior adjuvant therapy must have received 2 prior chemotherapy regimens for metastatic disease (e.g., FOLFOX followed by FOLFIRI)
• Patients who received prior adjuvant therapy with a fluoropyrimidine plus oxaliplatin must have received no more than 1 chemotherapy regimen for metastatic disease that must have contained irinotecan
• VEGF or EGFR inhibitors with prior chemotherapy allowed
• No known brain metastases
• Life expectancy \> 3 months
• ECOG performance status (PS) 0-2 or Karnofsky PS ≥ 60%

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Hedy Kindler
• Organization: The University of Chicago

hkindler@medicine.bsd.uchicago.edu

(773) 702-0360

Study Officials

• Hedy Kindler

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 19, 2014
• Results First Posted: September 10, 2013

Record last verified: 2011-10

Locations

US (1)