You are here

Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms, Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

NCT00599924
Pfizer
Completed
Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
NCT01945775
All Genders
18+
Years
Multiple Sites
Breast Neoplasms, Stomach Neoplasms, Esophagogastric Junction Neoplasm, Non-small-cell Lung Carcinoma
NCT03284723
All Genders
18+
Years
Multiple Sites
Breast Neoplasms
NCT01176916
Females
0+
Years
Multiple Sites
Neoplasms
NCT02659631
All Genders
18+
Years
Multiple Sites
Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies
This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX [Leucovorin + Fluorouracil (5-FU) + Oxaliplatin]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.
Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Neoplasms
  • Drug: sunitinib + FOLFOX
    37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
    Other Name: Sunitinib malate, SUTENT, mFOLFOX6
  • Drug: sunitinib + FOLFOX
    50 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
    Other Name: Sunitinib malate, SUTENT, mFOLFOX6
  • Drug: sunitinib + FOLFOX
    50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2)
    Other Name: Sunitinib malate, SUTENT, mFOLFOX6
  • Drug: sunitinib + FOLFOX
    37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
    Other Name: Sunitinib malate, SUTENT, mFOLFOX6
  • Drug: sunitinib + FOLFOX
    50 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
    Other Name: Sunitinib malate, SUTENT, mFOLFOX6
  • Drug: sunitinib + FOLFOX
    37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
    Other Name: Sunitinib malate, SUTENT, mFOLFOX6
  • Drug: sunitinib + FOLFOX
    25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
    Other Name: Sunitinib malate, SUTENT, mFOLFOX6
Experimental: Single arm

SU011248 [sunitinib] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle.

25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion

Interventions:
  • Drug: sunitinib + FOLFOX
  • Drug: sunitinib + FOLFOX
  • Drug: sunitinib + FOLFOX
  • Drug: sunitinib + FOLFOX
  • Drug: sunitinib + FOLFOX
  • Drug: sunitinib + FOLFOX
  • Drug: sunitinib + FOLFOX
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
November 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00599924
A6181048
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now