Status unknownNCT03053167Updated Feb 14, 2017

Irinotecan Plus Raltitrexed as Second-line Treatment in Advanced Colorectal Cancer Patients

A Phase 2 interventional study of Irinotecan and Raltitrexed in ColoRectal Cancer, sponsored by China Medical University, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-14.

Sponsored by China Medical University, China · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 100
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Read the detailed description

The standard initial treatment for patients with advanced colorectal cancer (ACC) not amenable for surgical resection is palliative 5-fluorouracil (5-FU)-based chemotherapy. However, response rates are low and prognosis remains poor, with median survival times about one year. Until recently, second-line therapy options were limited.

Irinotecan is a semisynthetic camptothecin derivate that acts as a DNA-topoisomerase-1 inhibitor,its most frequent toxic effects are diarrhea, neutropenia and cholinergic syndrome. Raltitrexed is a quinazoline folate-based specific thymidylate synthase inhibitor, its clinical activity in this setting is similar to that of modulated 5-FU regimens but with a better toxicity profile (mainly asthenia and increased serum transaminase levels). There seems to be no cross-resistance between 5-FU and raltitrexed. Irinotecan and raltitrexed have different toxicity profiles and modes of action. Both drugs are active as single agents and may be given as a short 3-weekly infusion, thus obviating complex schedules or the need for implantable venous access devices. Preclinical studies have demonstrated a pronounced sequence-dependent synergy between SN-38 (the active metabolite of irinotecan) and raltitrexed. It seems then interesting to explore the feasibility and therapeutic potential of this association.

With this background, the investigators have performed this study to evaluate efficacy and safety of irinotecan plus raltitrexed as second-line treatment in advanced colorectal cancer patients.

Conditions studied

ColoRectal Cancer

Browse trials for

Colorectal Neoplasms 5,599

Keywords

Raltitrexed
Irinotecan
Second-line Treatment
Advanced Colorectal Cancer(ACC)

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

China Medical University, China is the lead sponsor of 93 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
Irinotecan & Raltitrexed
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: Irinotecan · Drug: Raltitrexed

Interventions

DrugIrinotecan
Irinotecan: 180mg/㎡+NS250ml, ivgtt, 90min, d1 Every 3 weeks
Also known as: Campto
DrugRaltitrexed
Raltitrexed: 3mg/㎡+NS100ml，ivgtt，15min, d1 Every 3 weeks
Also known as: Sai wei jian

What researchers measure

Primary outcomes

Progression Free Survival [PFS]
Time frame: 5-6 months

Secondary outcomes

Overall Survival [OS]
Time frame: 12-15 months
Objective Response Rate [ORR]
Time frame: 12-15 months
Disease Control Rate [DCR]
Time frame: 12-15 months

Other outcomes

Incidence and Degree of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 12-15 months
Performance Status [WHO-ECOG]
Time frame: 12-15 months
Quality of Life [WHO-QOL]
Time frame: 12-15 months

Study locations

1 of 1 sites recruiting

The First Hospital of China Medical University
Shenyang, Liaoning 110001, China
- Yunpeng Liu, MD., PhD · Contact · cmuliuyunpeng@hotmail.com · 86-24-83282312
- Yunpeng Liu, MD., PhD. · Principal investigator
Recruiting

References and documents

Publications

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. PubMed 15865096 ↗
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. PubMed 15083176 ↗
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. PubMed 12187070 ↗
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. PubMed 12196368 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03053167
Lead sponsor: China Medical University, China
Collaborators: The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, Liaoning Cancer Hospital & Institute, Shengjing Hospital, General Hospital of Shenyang Military Region
Responsible party: Yunpeng Liu (Director of Department of Medical Oncology，The First Hospital of China Medical University, China Medical University, China) — Principal investigator
First posted: Feb 14, 2017
Start date: Dec 2016
Primary completion: Dec 2019 (estimated)
Completion: Dec 2020 (estimated)
Last update: Feb 14, 2017

Study contacts

YunPeng Liu, PhD

Contact

cmuliuyunpeng@hotmail.com

86-24-83282312

Zan Teng, PhD

Contact

tengzan@163.com

86-024-83282542

YunPeng Liu, PhD

principal investigator · First Hospital of China Medical University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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