Clinical trial NCT00631410: Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Official title: Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Neoplasms
Keywords: Phase 1
CRC
SU011248
Sunitinib
FOLFOX
Colorectal cancer
metastatic carcinoma of the colon or rectum
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 733 days (the last subject study discontinuation)
Secondary outcomes:
measure: Plasma Concentration of Sunitinib
timeFrame: Cycle 1 Day 14 and Cycle 2 Day 1
measure: Plasma Concentration of Sunitinib Active Metabolite (SU012662)
timeFrame: Cycle 1 Day 14 and Cycle 2 Day 1
measure: Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)
timeFrame: Cycle 1 Day 14 and Cycle 2 Day 1
measure: Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Up to the last subject completed Cycle 24 or individual study discontinuation
measure: Duration of Response (DR)
timeFrame: Up to 733 days (the last subject study discontinuation)
measure: Progression-Free Survival (PFS)
timeFrame: Up to 733 days (the last subject study discontinuation)
measure: Sunitinib Relative Dose Intensity in the Treatment Arm A
timeFrame: Up to 733 days (the last subject study discontinuation in the Treatment Arm A)
measure: Sunitinib Relative Dose Intensity in the Treatment Arm B
timeFrame: Up to 384 days (the last subject study discontinuation in the Treatment Arm B)
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Suntougun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: