NCT03053167

Brief Summary

Irinotecan and raltitrexed are active against advanced colorectal cancer (ACC), act through different mechanisms, and have only partially overlapping toxicity profiles. The purpose of this study is to evaluate efficacy and safety of irinotecan plus raltitrexed as second-line treatment in advanced colorectal cancer patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Dec 2016

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

3 years

First QC Date

January 23, 2017

Last Update Submit

February 13, 2017

Conditions

ColoRectal Cancer

Keywords

RaltitrexedIrinotecanSecond-line TreatmentAdvanced Colorectal Cancer(ACC)

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival [PFS]

    5-6 months

Secondary Outcomes (3)

  • Overall Survival [OS]

    12-15 months

  • Objective Response Rate [ORR]

    12-15 months

  • Disease Control Rate [DCR]

    12-15 months

Other Outcomes (3)

  • Incidence and Degree of Treatment-Emergent Adverse Events [Safety and Tolerability]

    12-15 months

  • Performance Status [WHO-ECOG]

    12-15 months

  • Quality of Life [WHO-QOL]

    12-15 months

Study Arms (1)

Irinotecan & Raltitrexed

EXPERIMENTAL

advanced colorectal cancer patients treated with irinotecan plus raltitrexed as second-line treatment. Irinotecan:180mg/㎡+NS250ml, ivgtt, 90min, d1 Raltitrexed: 3mg/㎡+NS100ml，ivgtt，15min, d1 Every 3 weeks

Drug: IrinotecanDrug: Raltitrexed

Interventions

IrinotecanDRUG

Irinotecan: 180mg/㎡+NS250ml, ivgtt, 90min, d1 Every 3 weeks

Also known as: Campto
Irinotecan & Raltitrexed
RaltitrexedDRUG

Raltitrexed: 3mg/㎡+NS100ml，ivgtt，15min, d1 Every 3 weeks

Also known as: Sai wei jian
Irinotecan & Raltitrexed

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • life expectancy of at least 3 months;
  • histological and/or cytological confirmation of ACC;
  • disease progression while on first-line palliative oxaliplatin \& fluoropyrimidine chemotherapy or relapse within 6 months after adjuvant oxaliplatin \& fluoropyrimidine chemotherapy;
  • wash-out time of 4 weeks after the last chemotherapy infusion or radiotherapy，and observed lesions not in the radiotherapy target；
  • at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；
  • ECOG performance status 0-1；
  • satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥90×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL);
  • For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment
  • written informed consent.

You may not qualify if:

  • prior exposure to irinotecan or raltitrexed;
  • chronic enteropathy on unresolved bowel obstruction;
  • Pregnant or lactated women;
  • previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin;
  • Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment；
  • cerebral metastases or leptomeningeal carcinomatosis;
  • severe or uncompensated concomitant medical conditions.
  • Unsuitable for the study or other chemotherapy determined by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Related Publications (5)

  • Chiara S, Nobile MT, Tomasello L, Acquati M, Taveggia P, Murolo C, Percivale P, Rosso R. Phase II trial of irinotecan and raltitrexed in chemotherapy-naive advanced colorectal cancer. Anticancer Res. 2005 Mar-Apr;25(2B):1391-6.

    PMID: 15865096RESULT

  • Feliu J, Salud A, Escudero P, Lopez-Gomez L, Pericay C, Castanon C, de Tejada MR, Rodriguez-Garcia JM, Martinez MP, Martin MS, Sanchez JJ, Baron MG; Oncopaz Cooperative Group and Associated Hospitals. Irinotecan plus raltitrexed as first-line treatment in advanced colorectal cancer: a phase II study. Br J Cancer. 2004 Apr 19;90(8):1502-7. doi: 10.1038/sj.bjc.6601713.

    PMID: 15083176RESULT

  • Aparicio J, de las Penas R, Vicent JM, Garcera S, Llorca C, Maestu I, Yuste AL, Farres J. Multicenter phase I study of irinotecan plus raltitrexed in patients with 5-fluorouracil-refractory advanced colorectal cancer. Oncology. 2002;63(1):42-7. doi: 10.1159/000065719.

    PMID: 12187070RESULT

  • Carnaghi C, Rimassa L, Garassino I, Zucali PA, Masci G, Fallini M, Morenghi E, Santoro A. Irinotecan and raltitrexed: an active combination in advanced colorectal cancer. Ann Oncol. 2002 Sep;13(9):1424-9. doi: 10.1093/annonc/mdf229.

    PMID: 12196368RESULT

  • Cheng Y, Teng Z, Zhang Y, Jin B, Zheng Z, Man L, Wang Z, Teng Y, Yu P, Shi J, Luo Y, Wang Y, Zhang J, Zhang H, Liu J, Chen H, Xiao J, Zhao L, Zhang L, Jiang Y, Chen Y, Zhang J, Wang C, Liu S, Qu J, Qu X, Liu Y. Irinotecan plus raltitrexed as second-line treatment in locally advanced or metastatic colorectal cancer patients: a prospective open-label, single-arm, multi-center, phase II study. BMC Cancer. 2024 Sep 2;24(1):1082. doi: 10.1186/s12885-024-12831-4.

    PMID: 39223545DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecanraltitrexed

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • YunPeng Liu, PhD

    First Hospital of China Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YunPeng Liu, PhD

CONTACT

86-24-83282312cmuliuyunpeng@hotmail.com

Zan Teng, PhD

CONTACT

86-024-83282542tengzan@163.com

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
Director of Department of Medical Oncology，The First Hospital of China Medical University

Study Record Dates

First Submitted

January 23, 2017

First Posted

February 14, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

CN(1)