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Colorectal NeoplasmsPhase 2NCT04683965

Pemetrexed and TAS-102 in Combination With Bevacizumab in Refractory Colorectal Cancer

A Phase 2 study testing Pemetrexed, TAS-102 and Bevacizumab in people with Colorectal Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Limited agents are optional after standard first and second line treatment for mCRC. Only Regorafenib and Fruquintinib are approved in China. PFS of these targeted drugs are not very long. Pemetrexed has shown significant efficacy in advanced lung cancer regarding PFS and OS with controllable toxicity. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Pemetrexed, TAS-102 and Bevacizumab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
1 Jan 2021to 1 May 2024
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

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
  • Subjects with metastatic colorectal cancer(CRC) (Stage IV).
  • Subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan.
  • Subjects have failed or refused third-line treatment with regorafenib or fruquintinib.
  • Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
  • Subjects who have withdrawn from standard treatment due to unacceptable toxicity and precluding retreatment with the same agent prior to progression of disease will also be allowed.
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  • Prior treatment with bevacizumab and/or cetuximab will be allowed, but the use of bevacizumab should be no more than one single line treatment.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.is necessary.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  • Life expectancy of at least 3 months.
  • Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.
  • Assigned informed consent.

Who cannot join

  • Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  • Participants of other clinical trial within 4 weeks.
  • Diseases which will impact the absorption of TAS-102, eg. dysphagia, chronic diarrhea, bowl obstruction
  • Hemorrhage events of ≥grade 3 within 4 weeks.
  • Known central nervous system metastasis.
  • Uncontrolled hypertension. (Systolic blood pressure 140 mmHg or diastolic pressure 90 mmHg despite optimal medical management). Unstable angina,congestive heart failure,Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
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  • Urine protein ≥++ and 24h urine protein more than 1.0g.
  • Chronically green wound or bone fracture.
  • Arterial or venous thrombotic or embolic events.
  • Tumor invading important blood vessel with high risk of severe hemorrhage.
  • Current active bleeding or any surgery taken within 2 months.
  • Abnormal coagulation function.
  • Thromboemboli events within 6 months.
  • Immune diseases or organ transplantation history.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: A Single Arm, Open Label, Exploratory Study of Pemetrexed and TAS-102 in Combination With Bevacizumab in Patients Who Have Progressed After Standard Second Line Therapy

Limited agents are optional after standard first and second line treatment for mCRC. Only Regorafenib and Fruquintinib are approved in China. PFS of these targeted drugs are not very long. Pemetrexed has shown significant efficacy in advanced lung cancer regarding PFS and OS with controllable toxicity. TAS-102 has been used in colorectal cancer with promising outcomes. Bevacizumab is also an important monoclonal antibody which could make benefits in treated patients. This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.

Being tested
Pemetrexed, TAS-102, Bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • PemetrexedDrug

    Pemetrexed 500 mg/m2 d1

  • TAS-102Drug

    Also called LONSURF

    TAS-102, capsule, 35mg/m2, bid,p.o, d1~5,d8~12

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab 5 mg/kg d1,d14

Study groups in NCT04683965
Study groupRoleWhat they receive
Pemetrexed + TAS-102 + BevacizumabExperimentalPemetrexed 500 mg/m2 d1+ TAS-102, capsule, 35mg/m2, bid,po, d1~5, d8~12 + Bevacizumab 5 mg/kg d1, d14; Repeated every 4 weeks
Receives: Drug: Pemetrexed; Drug: TAS-102; Drug: Bevacizumab

What is being measured

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

  1. Objective response rate(ORR)

    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before November 1,2021

Secondary outcomes (4)

  1. Progression-free Survival(PFS)

    PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before November 1,2021

  2. Overall Survival (OS)

    OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

    Measured: From assignment of the first subject until 40 death events observed, up to 2 years.

  3. Disease control rate (DCR)

    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before November 1,2021

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    adverse events will be assessed according to CTCAE v4.0, including hematological and non-hematological adverse events. Non-hematological adverse events will be collected by patients reported outcomes questionaire. The adverse events of interest include hypertension,hand-foot syndrome,proteinuria,hoarseness,rash,etc.The dose reduction and drug discontinuance due to adverse events will also be recorded.

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before November 1,2021

Timeline

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

  1. First posted24 Dec 2020
  2. Study start1 Jan 2021
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 May 2024 (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
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683965
Sponsor's protocol ID
KEEP-G 06
Status last verified
Jul 2022
First submitted
22 Dec 2020
Last updated
2 Aug 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu XY, Huang XE, You SX, Lu YY, Cao J, Liu J. Phase II study of pemetrexed as second or third line combined chemotherapy in patients with colorectal cancer. Asian Pac J Cancer Prev. 2013;14(3):2019-22. doi: 10.7314/apjcp.2013.14.3.2019.

    PubMed 23679311

  • Passardi A, Fanini F, Turci L, Foca F, Rosetti P, Ruscelli S, Casadei Gardini A, Valgiusti M, Dazzi C, Marangolo M. Prolonged Pemetrexed Infusion Plus Gemcitabine in Refractory Metastatic Colorectal Cancer: Preclinical Rationale and Phase II Study Results. Oncologist. 2017 Aug;22(8):886-e79. doi: 10.1634/theoncologist.2017-0206. Epub 2017 Jun 7.

    PubMed 28592624

  • Lim SW, Lee S, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK, Kim ST. Pemetrexed Monotherapy as Salvage Treatment in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapy: A Phase II Single-arm Prospective Trial. J Cancer. 2018 Jul 30;9(16):2910-2915. doi: 10.7150/jca.24948. eCollection 2018.

    PubMed 30123359

  • Yu Z, Wang J, Cai X, Gao Z, Wang S, Gu Y. Analysis of pemetrexed-based chemotherapy in the treatment of advanced colorectal cancer. Ann Transl Med. 2020 Nov;8(21):1368. doi: 10.21037/atm-20-1095.

    PubMed 33313113

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed, TAS-102 and Bevacizumab in people with Colorectal Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University 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 12 inclusion and 14 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 2 Aug 2022. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate(ORR) (time frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before November 1,2021). 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 NCT04683965, which also lists 4 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 2 Aug 2022.

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