Clinical trial NCT00668863: Study Of Sunitinib With FOLFIRI In Colorectal Cancer
Official title: A Phase II Study Of Sunitinib In Combination With Irinotecan, L-leucovorin, And 5-Fluorouracil In Patients With Unresectable Or Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unresectable or Metastatic Colorectal Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients


Eligibility criteria: Inclusion Criteria:

* Patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with unresectable or metastatic disease documented on diagnostic imaging studies.
* Patient must have at least one RECIST-defined measurable lesion that has not been treated with prior local therapy.

Exclusion Criteria:

* History of another primary malignancy within 3 years prior to study entry, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
* Current, recent, or planned participation in an experimental treatment drug study other than this protocol.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 11 cycles (1 cycle = 6 weeks)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 11 cycles (1 cycle = 6 weeks)
measure: Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)
timeFrame: Up to 11 cycles (1 cycle = 6 weeks)
measure: Duration of Response (DR)
timeFrame: Up to 11 cycles (1 cycle = 6 weeks)
measure: Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.
timeFrame: Cycle 1 Day 15
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib
timeFrame: Cycle 1 Day 15
measure: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib
timeFrame: Cycle 1 Day 15
measure: Apparent Oral Clearance (CL/F) of Sunitinib
timeFrame: Cycle 1 Day 15
measure: Maximum Observed Plasma Concentration (Cmax) of Irinotecan
timeFrame: Cycle 1 Day 15
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan
timeFrame: Cycle 1 Day 15
measure: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan
timeFrame: Cycle 1 Day 15
measure: Terminal Phase Elimination Half-life (t1/2) of Irinotecan
timeFrame: Cycle 1 Day 15
measure: Clearance of Irinotecan
timeFrame: Cycle 1 Day 15
measure: Volume of Distribution at Steady State (Vss) of Irinotecan
timeFrame: Cycle 1 Day 15
measure: Plasma Concentration at Steady State (Css) of 5-FU
timeFrame: Cycle 1 Day 15
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE).
timeFrame: Up to 11 cycles (1 cycle = 6 weeks)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Chiba-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba-ken
city: Matsuyama-shi
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Sapporo-shi
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kochi-shi
country: Japan
facility: Pfizer Investigational Site
state: Kochi
city: Saku
country: Japan
facility: Pfizer Investigational Site
state: Nagano
city: Osakasayama-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Takatsuki
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Shimotsuke-shi
country: Japan
facility: Pfizer Investigational Site
state: Tochigi
city: Minoh/Osaka
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tsuji Y, Satoh T, Tsuji A, Muro K, Yoshida M, Nishina T, Nagase M, Komatsu Y, Kato T, Miyata Y, Mizutani N, Hashigaki S, Lechuga MJ, Denda T. First-line sunitinib plus FOLFIRI in Japanese patients with unresectable/metastatic colorectal cancer: a phase II study. Cancer Sci. 2012 Aug;103(8):1502-7. doi: 10.1111/j.1349-7006.2012.02320.x. Epub 2012 Jun 14.