CClinicalTrials.gg
Sign In
CompletedNCT00599924Updated Jul 15, 2015Results posted

Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

A Phase 1 interventional study of sunitinib + FOLFOX and sunitinib + FOLFOX in Colorectal Neoplasms and Neoplasms, sponsored by Pfizer. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-15.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Colorectal Neoplasms
  • Neoplasms

Keywords

  • advanced solid tumors,
  • colorectal cancer,
  • sunitinib (SUTENT),
  • FOLFOX
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 53 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • 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

    Drug: sunitinib + FOLFOX

Interventions

  • Drugsunitinib + FOLFOX

    37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)

    Also known as: Sunitinib malate, SUTENT, mFOLFOX6

  • Drugsunitinib + FOLFOX

    50 mg sunitinib + modified FOLFOX6 (Schedule 2/2)

    Also known as: Sunitinib malate, SUTENT, mFOLFOX6

  • Drugsunitinib + FOLFOX

    50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2)

    Also known as: Sunitinib malate, SUTENT, mFOLFOX6

  • Drugsunitinib + FOLFOX

    37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2)

    Also known as: Sunitinib malate, SUTENT, mFOLFOX6

  • Drugsunitinib + FOLFOX

    50 mg sunitinib + modified FOLFOX6 (Schedule 4/2)

    Also known as: Sunitinib malate, SUTENT, mFOLFOX6

  • Drugsunitinib + FOLFOX

    37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)

    Also known as: Sunitinib malate, SUTENT, mFOLFOX6

  • Drugsunitinib + FOLFOX

    25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)

    Also known as: Sunitinib malate, SUTENT, mFOLFOX6

06

What researchers measure

Primary outcomes

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

    All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.

    Time frame: up to 20 weeks

Secondary outcomes

  1. Objective Response (OR)

    From the start of treatment until disease progression/recurrence. OR=confirmed Complete Response (CR) or confirmed Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR = disappearance of all target lesions. CR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. PR = ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.

    Time frame: From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)

  2. Maximum Plasma Concentration (Cmax) of Sunitinib

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  3. Time to Cmax (Tmax) of Sunitinib

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  4. Minimum Plasma Concentration (Cmin) of Sunitinib

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  5. Clearance (CL/F) of Sunitinib

    Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  6. Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib

    AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  7. Terminal Phase Half-Life (t1/2) of Sunitinib

    t1/2 = terminal phase half-life. t1/2 was obtained by natural log of 2 (ln2) divided by the rate constant for terminal phase (kel).

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  8. Cmax of SU-012662 (Sunitinib's Metabolite)

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  9. Tmax of SU-012662 (Sunitinib's Metabolite)

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  10. Cmin of SU-012662 (Sunitinib's Metabolite)

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  11. AUC24 for SU-012662 (Sunitinib's Metabolite)

    AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.

  12. CL/F of SU-012662 (Sunitinib's Metabolite)

    CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  13. T1/2 of SU-012662 (Sunitinib's Metabolite)

    t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  14. Cmax of Free Platinum

    Oxaliplatin was metabolized to platinum and free platinum was measured.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  15. Tmax of Free Platinum

    Oxaliplatin was metabolized to platinum and free platinum was measured.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  16. Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum

    Oxaliplatin was metabolized to platinum and free platinum was measured. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. AUCinf was obtained by the Linear/Log trapezoidal method.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  17. T1/2 for Free Platinum

    t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free platinum was measured.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  18. Cmax of Total Platinum

    Oxaliplatin was metabolized to platinum and total platinum was measured.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  19. Tmax of Total Platinum

    Oxaliplatin was metabolized to platinum and total platinum was measured.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  20. Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum

    Oxaliplatin was metabolized to platinum and total platinum was measured. AUC48 = Area under the plasma concentration-time profile from time zero (pre-dose) to forty-eight hours. AUC48 was obtained by the Linear/Log trapezoidal method.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  21. Steady State Concentration (Css) of Fluorouracil (5-FU)

    Steady state is reached when the amount of drug getting into the system per unit time is equal to the amount of drug cleared from the system.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  22. Steady State Clearance (CLss) of 5-FU

    CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  23. Area Under the Curve (AUC) of 5-FU

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  24. Cmax of 5-FU

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  25. T1/2 of Free Platinum, Total Platinum, and 5-FU

    t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free and total platinum were measured.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  26. CL/F of Free Platinum, Total Platinum, and 5-FU

    CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.

    Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

  27. Cmin of Free Platinum, Total Platinum, and 5-FU

    Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

  28. Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)

    Volume endothelial Ktrans was estimated by fitting the tissue contrast agent time course to the Kety equation (Tofts model for analysis of DCE-MRI data).

    Time frame: Cycle 3 (Day 1), Cycle 3 (Day 8)

  29. Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI

    IAUC: The initial area under the curve was estimated by integrating the area under the contrast agent concentration time course for the first 90 seconds after bolus arrival in the tumor.

    Time frame: Cycle 3 (Day 1) and Cycle 3 (Day 8)

07

Results

Posted Dec 9, 2009

Participant flow

Participant flow — Overall Study
Milestone37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Started49512968
Completed1434323
Not completed3528645
Withdrew: Lack of efficacy3512320
Withdrew: Adverse event0002002
Withdrew: Death0002021
Withdrew: Protocol violation0001000
Withdrew: Withdrawal by subject0010100
Withdrew: Other0001202

Outcome measures

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

All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.

Time frame:
up to 20 weeks
Reported as:
Number · participants
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
participants37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
AEs49512968
SAEs0407324
SecondaryObjective Response (OR)

From the start of treatment until disease progression/recurrence. OR=confirmed Complete Response (CR) or confirmed Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR = disappearance of all target lesions. CR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. PR = ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.

Time frame:
From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)
Reported as:
Number · participants
Objective Response (OR)
participants37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Objective Response (OR)0200002
SecondaryMaximum Plasma Concentration (Cmax) of Sunitinib
Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Reported as:
Mean · ng/mL
Maximum Plasma Concentration (Cmax) of Sunitinib
ng/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 1447.13 ± 13.16561.36 ± 14.692
Cycle 2, Day 144.95 ± 14.27260.24 ± 13.830
SecondaryTime to Cmax (Tmax) of Sunitinib
Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Reported as:
Median · hours
Time to Cmax (Tmax) of Sunitinib
hours37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 148.00 (6.00 to 10.00)10.00 (4.00 to 10.00)
Cycle 2, Day 17.00 (6.00 to 24.00)8.00 (4.00 to 10.00)
SecondaryMinimum Plasma Concentration (Cmin) of Sunitinib
Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Reported as:
Mean · ng/mL
Minimum Plasma Concentration (Cmin) of Sunitinib
ng/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 1434.95 ± 10.61838.23 ± 11.629
Cycle 2, Day 130.28 ± 10.18839.47 ± 16.632
SecondaryClearance (CL/F) of Sunitinib

Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.

Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Reported as:
Mean · L/hr
Clearance (CL/F) of Sunitinib
L/hr37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 1441.13 ± 10.10444.29 ± 5.663
Cycle 2, Day 142.40 ± 12.70049.44 ± 16.211
SecondaryArea Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib

AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.

Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Reported as:
Mean · ng*hr/mL
Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib
ng*hr/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 14985.43 ± 251.0461233.73 ± 322.353
Cycle 2, Day 1948.40 ± 284.8711202.50 ± 396.337
SecondaryTerminal Phase Half-Life (t1/2) of Sunitinib

t1/2 = terminal phase half-life. t1/2 was obtained by natural log of 2 (ln2) divided by the rate constant for terminal phase (kel).

Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

No measurements were reported for this outcome.

SecondaryCmax of SU-012662 (Sunitinib's Metabolite)
Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Reported as:
Mean · ng/mL
Cmax of SU-012662 (Sunitinib's Metabolite)
ng/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 1418.95 ± 3.00722.80 ± 5.189
Cycle 2, Day 118.75 ± 2.97723.44 ± 7.094
SecondaryTmax of SU-012662 (Sunitinib's Metabolite)
Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Reported as:
Median · hours
Tmax of SU-012662 (Sunitinib's Metabolite)
hours37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 148.00 (6.00 to 10.00)10.00 (0.00 to 24.00)
Cycle 2, Day 115.00 (0.00 to 24.00)4.00 (2.00 to 24.00)
SecondaryCmin of SU-012662 (Sunitinib's Metabolite)
Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Reported as:
Mean · ng/mL
Cmin of SU-012662 (Sunitinib's Metabolite)
ng/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 1414.45 ± 3.49715.70 ± 4.365
Cycle 2, Day 113.59 ± 4.58517.68 ± 5.599
SecondaryAUC24 for SU-012662 (Sunitinib's Metabolite)

AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.

Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.
Reported as:
Mean · ng*hr/mL
AUC24 for SU-012662 (Sunitinib's Metabolite)
ng*hr/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 14401.51 ± 63.164468.79 ± 117.108
Cycle 2, Day 1395.82 ± 66.618495.97 ± 154.314
SecondaryCL/F of SU-012662 (Sunitinib's Metabolite)

CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.

Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

No measurements were reported for this outcome.

SecondaryT1/2 of SU-012662 (Sunitinib's Metabolite)

t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.

Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

No measurements were reported for this outcome.

SecondaryCmax of Free Platinum

Oxaliplatin was metabolized to platinum and free platinum was measured.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Mean · ng/mL
Cmax of Free Platinum
ng/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 1935.25 ± 442.974634.00 ± 134.050
Cycle 2, Day 11043.75 ± 381.656789.43 ± 239.650
SecondaryTmax of Free Platinum

Oxaliplatin was metabolized to platinum and free platinum was measured.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Median · hours
Tmax of Free Platinum
hours37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 12.00 (1.00 to 2.00)2.00 (1.00 to 2.00)
Cycle 2, Day 12.00 (2.00 to 2.00)2.00 (1.00 to 2.00)
SecondaryArea Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum

Oxaliplatin was metabolized to platinum and free platinum was measured. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. AUCinf was obtained by the Linear/Log trapezoidal method.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Mean · ng*hr/mL
Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum
ng*hr/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 17459.28 ± 2892.4426490.17 ± 1947.621
Cycle 2, Day 17942.64 ± 3043.5677092.65 ± 1906.756
SecondaryT1/2 for Free Platinum

t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free platinum was measured.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Mean · hours
T1/2 for Free Platinum
hours37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 116.15 ± 3.07715.60 ± 2.038
Cycle 2, Day 118.55 ± 5.62231.20 ± 37.925
SecondaryCmax of Total Platinum

Oxaliplatin was metabolized to platinum and total platinum was measured.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Mean · ng/mL
Cmax of Total Platinum
ng/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 12490.00 ± 748.4652137.14 ± 415.681
Cycle 2, Day 12905.00 ± 636.6842641.43 ± 387.145
SecondaryTmax of Total Platinum

Oxaliplatin was metabolized to platinum and total platinum was measured.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Median · hours
Tmax of Total Platinum
hours37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 12.00 (2.00 to 2.00)2.00 (1.00 to 2.00)
Cycle 2, Day 12.00 (2.00 to 2.00)2.00 (2.00 to 2.00)
SecondaryArea Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum

Oxaliplatin was metabolized to platinum and total platinum was measured. AUC48 = Area under the plasma concentration-time profile from time zero (pre-dose) to forty-eight hours. AUC48 was obtained by the Linear/Log trapezoidal method.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Mean · ng*hr/mL
Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum
ng*hr/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 147264.02 ± 10509.55643713.95 ± 5590.750
Cycle 2, Day 156813.62 ± 11980.02951962.03 ± 8118.343
SecondarySteady State Concentration (Css) of Fluorouracil (5-FU)

Steady state is reached when the amount of drug getting into the system per unit time is equal to the amount of drug cleared from the system.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Mean · ng/mL
Steady State Concentration (Css) of Fluorouracil (5-FU)
ng/mL37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 1567.52 ± 351.207334.26 ± 89.579
Cycle 2, Day 1598.86 ± 127.635647.32 ± 284.203
SecondarySteady State Clearance (CLss) of 5-FU

CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Reported as:
Mean · L/hr
Steady State Clearance (CLss) of 5-FU
L/hr37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Cycle 1, Day 1284.99 ± 147.808312.63 ± 93.563
Cycle 2, Day 1174.51 ± 49.445201.12 ± 103.534
SecondaryArea Under the Curve (AUC) of 5-FU
Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

No measurements were reported for this outcome.

SecondaryCmax of 5-FU
Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

No measurements were reported for this outcome.

SecondaryT1/2 of Free Platinum, Total Platinum, and 5-FU

t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free and total platinum were measured.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

No measurements were reported for this outcome.

SecondaryCL/F of Free Platinum, Total Platinum, and 5-FU

CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.

Time frame:
pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose

No measurements were reported for this outcome.

SecondaryCmin of Free Platinum, Total Platinum, and 5-FU
Time frame:
pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose

No measurements were reported for this outcome.

SecondaryVolume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)

Volume endothelial Ktrans was estimated by fitting the tissue contrast agent time course to the Kety equation (Tofts model for analysis of DCE-MRI data).

Time frame:
Cycle 3 (Day 1), Cycle 3 (Day 8)

No measurements were reported for this outcome.

SecondaryInitial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI

IAUC: The initial area under the curve was estimated by integrating the area under the contrast agent concentration time course for the first 90 seconds after bolus arrival in the tumor.

Time frame:
Cycle 3 (Day 1) and Cycle 3 (Day 8)

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)—0/4 (0%)4/4 (100%)
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)—4/9 (44.4%)9/9 (100%)
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)—0/5 (0%)5/5 (100%)
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)—7/12 (58.3%)12/12 (100%)
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)—3/9 (33.3%)9/9 (100%)
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)—2/6 (33.3%)6/6 (100%)
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)—4/8 (50%)8/8 (100%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
Event37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Disease progressionGeneral disorders0/40/90/51/120/92/60/8
SepsisInfections and infestations0/40/90/51/120/90/62/8
PyrexiaGeneral disorders0/42/90/52/120/90/60/8
Abdominal painGastrointestinal disorders0/40/90/52/120/90/60/8
AnorexiaMetabolism and nutrition disorders0/40/90/50/120/91/60/8
DehydrationMetabolism and nutrition disorders0/41/90/51/120/91/60/8
Disseminated intravascular coagulationBlood and lymphatic system disorders0/40/90/50/120/90/61/8
ThrombocytopeniaBlood and lymphatic system disorders0/41/90/50/120/90/61/8
Hepatic failureHepatobiliary disorders0/40/90/50/120/90/61/8
InfectionInfections and infestations0/40/90/50/120/90/61/8
Most frequent other events
Showing 10 of 76
Most frequent other events
Event37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
NeutropeniaBlood and lymphatic system disorders4/49/93/55/128/94/65/8
VomitingGastrointestinal disorders0/45/94/55/125/95/63/8
FatigueGeneral disorders2/46/92/56/127/95/64/8
DiarrhoeaGastrointestinal disorders1/44/94/54/125/92/63/8
NauseaGastrointestinal disorders1/45/94/57/125/94/65/8
AnaemiaBlood and lymphatic system disorders3/47/90/53/123/91/61/8
ThrombocytopeniaBlood and lymphatic system disorders3/46/92/52/125/93/63/8
Mucosal inflammationGeneral disorders2/41/93/53/124/92/61/8
Abdominal painGastrointestinal disorders0/45/91/52/124/93/63/8
ConstipationGastrointestinal disorders2/45/91/54/122/91/61/8

Baseline characteristics

Age, Customized
Age, Customized(participants)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)Total
< 65 years265766537
> = 65 years230530316
Sex: Female, Male
Sex: Female, Male(Participants)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)Total
Female142612319
Male353684534
08

Study locations

3 sites
  • Pfizer Investigational Site
    Aurora, Colorado 80045, United States
  • Pfizer Investigational Site
    Nashville, Tennessee 37232, United States
  • Pfizer Investigational Site
    Dallas, Texas 75246, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00599924
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jan 24, 2008
Start date
Sep 2005
Primary completion
Nov 2008
Completion
Nov 2008
Results posted
Dec 9, 2009
Last update
Jul 15, 2015

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Pfizer

Start the discussion