| Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
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| Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies
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| 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.
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| Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.
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| Interventional
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| Phase 1
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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- Colorectal Neoplasms
- Neoplasms
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- 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
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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
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| Not Provided
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| Completed
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| 53
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| 80
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| November 2008
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| November 2008 (Final data collection date for primary outcome measure)
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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
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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| United States
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| NCT00599924
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| A6181048
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| No
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| Not Provided
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| Not Provided
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| June 2015
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