Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

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NCT00599924

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Study Location
Pfizer Investigational Site
Aurora, Colorado, 80045, United States
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Contact
1-800-718-1021
[email protected]
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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

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Colorectal Neoplasms, NeoplasmsStudy Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
NCT00599924
  1. Aurora, Colorado
  2. Nashville, Tennessee
  3. Dallas, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
Official Title  ICMJE Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies
Brief Summary 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.
Detailed Description Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2009)		53
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2008)		80
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00599924
Other Study ID Numbers  ICMJE A6181048
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP