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ColoRectal CancerPhase 2NCT03053167

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

A Phase 2 study testing Irinotecan and Raltitrexed in people with ColoRectal Cancer, run by China Medical University, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
ColoRectal Cancer
What is being tested?
Irinotecan and Raltitrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Dec 2016to Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

YunPeng Liu, PhD contact

86-24-83282312

cmuliuyunpeng@hotmail.com

Zan Teng, PhD contact

86-024-83282542

tengzan@163.com

China1 site, 1 recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Yunpeng Liu, MD., PhD, 86-24-83282312, cmuliuyunpeng@hotmail.com

    Yunpeng Liu, MD., PhD.

    Recruiting

Other trials in China

About this study

Official title: Irinotecan Plus Raltitrexed as Second-line Treatment in Advanced Colorectal Cancer Patients: An Open-label, Single-arm, Multicenter Phase II Study

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.

Being tested
Irinotecan, Raltitrexed
Keywords
Raltitrexed, Irinotecan, Second-line Treatment, Advanced Colorectal Cancer(ACC)
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IrinotecanDrug

    Also called Campto

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

  • RaltitrexedDrug

    Also called Sai wei jian

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

Study groups in NCT03053167
Study groupRoleWhat they receive
Irinotecan & RaltitrexedExperimentaladvanced 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
Receives: Drug: Irinotecan; Drug: Raltitrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival [PFS]

    Measured: 5-6 months

Secondary outcomes (3)

  1. Overall Survival [OS]

    Measured: 12-15 months

  2. Objective Response Rate [ORR]

    Measured: 12-15 months

  3. Disease Control Rate [DCR]

    Measured: 12-15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study startDec 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03053167
Sponsor's protocol ID
CLOG1602
Status last verified
Feb 2017
First submitted
23 Jan 2017
Last updated
14 Feb 2017
Results posted
No
Data monitoring committee
Yes

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

  • 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.

    PubMed 39223545

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan and Raltitrexed in people with ColoRectal Cancer, run by China Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact YunPeng Liu, PhD (86-24-83282312, cmuliuyunpeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival [PFS] (time frame: 5-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03053167, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.

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