NCT01322152

Brief Summary

The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

March 23, 2011

Last Update Submit

June 10, 2013

Conditions

Colorectal Cancer

Keywords

metastasesneoplasm

Outcome Measures

Primary Outcomes (1)

  • Rate of Diarrhea

    eight weeks

Secondary Outcomes (5)

  • Progression free survival

    eight weeks

  • Response rate

    eight weeks

  • Disease control rate

    eight weeks

  • Overall survival

    eight weeks

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    eight weeks

Study Arms (1)

wXELIRI regimen

EXPERIMENTAL
Drug: irinotecan, capecitabine

Interventions

irinotecan, capecitabineDRUG

Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.

wXELIRI regimen

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Histologically confirmed colorectal cancer
  • Age 18-70 years old
  • Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before
  • Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • ECOG 0-1
  • Life expectancy of more than 3 months.
  • Normal laboratory values: hemoglobin \> 90g/dl, neutrophils \> 1.5×10\^9/L, platelets \> 100×10\^9/L, serum creatinine \< 1.5×upper limit of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN, AKP \< 4×ULN

You may not qualify if:

  • Pregnant or lactating patients
  • Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
  • Active or uncontrolled infection
  • Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
  • Patients could not swallow the tablets
  • Concomitant with brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

  • Li W, Xu J, Shen L, Liu T, Guo W, Zhang W, Chen Z, Zhu X, Li J. Phase II study of weekly irinotecan and capecitabine treatment in metastatic colorectal cancer patients. BMC Cancer. 2014 Dec 19;14:986. doi: 10.1186/1471-2407-14-986.

    PMID: 25527007DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisNeoplasms

Interventions

IrinotecanCapecitabine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jin Li, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

CN(1)