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Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Neoplasms

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Trial Information

Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies


Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized,
Safety Study.


Inclusion Criteria:



- Advanced solid tumor malignancy (during expansion at the maximum tolerated dose,
entry will be limited to patients wtih adenocarcinoma of the colon or rectum)

- Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

- Prior treatment with more than 6 cycles of traditional alkylating agent-based
chemotherapy regimens

- Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens

- For colorectal cancer patients in the expanded cohorts, prior treatment with more
than 2 systemic chemotherapy regimens in the metastatic setting

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Outcome Time Frame:

up to 20 weeks

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181048

NCT ID:

NCT00599924

Start Date:

September 2005

Completion Date:

November 2008

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • advanced solid tumors,
  • colorectal cancer,
  • sunitinib (SUTENT),
  • FOLFOX
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteBristol, Tennessee  37620