Know Cancer

or
forgot password

Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer


Phase 1
20 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with
documented locally advanced or metastatic disease.

- Evidence of unidimensionally measurable disease as defined by the Response Evaluation
Criteria in Solid Tumors (RECIST).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

- Prior treatment with systemic therapy for locally advanced or metastatic colorectal
cancer.

- Prior surgery or investigational agent within 4 weeks prior to study entry.

- Pregnancy or breastfeeding. All female patients of reproductive potential must have
a negative pregnancy test (serum or urine) prior to the start of the study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events

Outcome Description:

Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.

Outcome Time Frame:

Up to 733 days (the last subject study discontinuation)

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

A6181148

NCT ID:

NCT00631410

Start Date:

January 2008

Completion Date:

March 2010

Related Keywords:

  • Colorectal Neoplasms
  • Phase 1
  • CRC
  • SU011248
  • Sunitinib
  • FOLFOX
  • Colorectal cancer
  • metastatic carcinoma of the colon or rectum
  • Neoplasms
  • Colorectal Neoplasms

Name

Location