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Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00631410
Pfizer
Completed
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

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Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Neoplasms
  • Drug: sunitinib + mFOLFOX6
    37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
  • Drug: sunitinib + mFOLFOX6
    50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)
  • Experimental: A
    Intervention: Drug: sunitinib + mFOLFOX6
  • Experimental: B
    Intervention: Drug: sunitinib + mFOLFOX6
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2010
July 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00631410
A6181148
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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