Study Of Sunitinib With FOLFIRI In Colorectal Cancer

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NCT00668863

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Study Location
Pfizer Investigational Site
Nagoya, Aichi, , Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Unresectable or Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Unresectable or Metastatic Colorectal CancerStudy Of Sunitinib With FOLFIRI In Colorectal Cancer NCT00668863
  1. Nagoya, Aichi
  2. Chiba-shi, Chiba-ken
  3. Matsuyama-shi, Ehime
  4. Sapporo-shi, Hokkaido
  5. Sapporo, Hokkaido
  6. Kochi-shi, Kochi
  7. Saku, Nagano
  8. Osakasayama-shi, Osaka
  9. Takatsuki, Osaka
  10. Shimotsuke-shi, Tochigi
  11. Minoh/Osaka,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib With FOLFIRI In Colorectal Cancer
Official Title  ICMJE A Phase II Study Of Sunitinib In Combination With Irinotecan, L-leucovorin, And 5-Fluorouracil In Patients With Unresectable Or Metastatic Colorectal Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unresectable or Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)
    FOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
  • Drug: Sunitinib
    37.5mg daily P.O., 4 weeks On 2weeks Off each 42 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
    Other Name: Sutent
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)
  • Drug: Sunitinib
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2010)		71
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2008)		70
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00668863
Other Study ID Numbers  ICMJE A6181151
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP