Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631410
• Other study ID #: A6181148
• Status: Completed
• Phase: Phase 1
• First received: January 2, 2008
• Last updated: March 11, 2011
• Start date: January 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• sunitinib + mFOLFOX6
37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
• sunitinib + mFOLFOX6
50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chuo-ku	Tokyo
Japan	Pfizer Investigational Site	Kashiwa	Chiba
Japan	Pfizer Investigational Site	Suntougun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.	Up to 733 days (the last subject study discontinuation)	Yes
Secondary	Plasma Concentration of Sunitinib	Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.	Cycle 1 Day 14 and Cycle 2 Day 1	No
Secondary	Plasma Concentration of Sunitinib Active Metabolite (SU012662)	Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.	Cycle 1 Day 14 and Cycle 2 Day 1	No
Secondary	Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)	Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.	Cycle 1 Day 14 and Cycle 2 Day 1	No
Secondary	Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)	Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.	Up to the last subject completed Cycle 24 or individual study discontinuation	No
Secondary	Duration of Response (DR)	Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.	Up to 733 days (the last subject study discontinuation)	No
Secondary	Progression-Free Survival (PFS)	Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.	Up to 733 days (the last subject study discontinuation)	No
Secondary	Sunitinib Relative Dose Intensity in the Treatment Arm A	Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period"n": Cycle (n-1)*3+1 to n*3.	Up to 733 days (the last subject study discontinuation in the Treatment Arm A)	No
Secondary	Sunitinib Relative Dose Intensity in the Treatment Arm B	Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period"n": Cycle (n-1)*2+1 to n*2.	Up to 384 days (the last subject study discontinuation in the Treatment Arm B)	No

External Links

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