NeoplasmPhase 2BATTLENCT02226289
Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
A Phase 2 study testing Bevacizumab in people with Neoplasm and Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and second-line treatment for metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Colorectal Cancer, Metastatic Neoplasm
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Sep 2020to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained.
- Subjects must be able to understand and willing to sign a written informed consent.
- Subjects > 18 years of age
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
- Histological or cytological diagnosis of adenocarcinoma of the colon or rectum.
- Subjects have unresectable metastatic lesions.
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- Subjects failed to respond to oxaliplatin, irinotecan and fluorouracil.
- Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration.
- Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.
- Total bilirubin ≤1.5 x the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
- Amylase and lipase ≤ 1.5 x the ULN.
- Serum creatinine ≤ 1.5 x the ULN.
- Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
Who cannot join
- Any previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to this study.
- Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks before start of study medication.
- Uncontrolled hypertension. (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
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- Any evidence of active infection.
- Known history of human immunodeficiency virus (HIV) infection.
- History of bleeding diathesis or coagulopathy.
- History of interstitial pneumonitis or pulmonary fibrosis
- Pregnancy or lactation at the time of study entry.
- Any history of or currently known brain metastases.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Any illness or medical conditions that are unstable or could jeopardize the safety of the subjects and his/her compliance in the study.
- Subjects with known allergy to the study drugs or to any of its excipients.
- Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Jian Xiao, Ph D, 86-20-38250745, xiaoj26@mail.sysu.edu.cn
Ping Lan, Ph D
About this study
Official title: Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment
Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.
Read the detailed description
This is a single arm, phase II, open-labelled clinical trial to evaluate the safety and efficacy of bevacizumab combined with cytotoxic agents in the treatment of patients with mCRC progressing under all available cytotoxic chemotherapy
- Conditions
- Neoplasm, Colorectal Cancer, Metastatic Neoplasm
- Being tested
- Bevacizumab
- Keywords
- bevacizumab, refractory, colorectal cancer, metastatic
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
bevacizumab with the latest received cytotoxic regimen
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab-containing | Experimental | bevacizumab with the latest received cytotoxic regimen Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Percentage of tumor regression
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Overall survival
From date of treatment until the date of death of any cause
Measured: From date of treatment until the date of death of any cause, assessed up to 48 months
Progression free survival
From date of treatment until the date of disease progression
Measured: From date of treatment until the date of disease progression, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startSep 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Ping Lan, Ph D, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226289
- Sponsor's protocol ID
- BATTLE
- Acronym
- BATTLE
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2014
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment
- ClinicalTrials.gov ID
- NCT02226289
- Acronym / sponsor ID
- BATTLE / BATTLE
- Conditions
- Neoplasm, Colorectal Cancer, Metastatic Neoplasm
- Keywords
- bevacizumab, refractory, colorectal cancer, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.
Detailed description
This is a single arm, phase II, open-labelled clinical trial to evaluate the safety and efficacy of bevacizumab combined with cytotoxic agents in the treatment of patients with mCRC progressing under all available cytotoxic chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab-containing | Experimental | Drug: Bevacizumabbevacizumab with the latest received cytotoxic regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent obtained.
- Subjects must be able to understand and willing to sign a written informed consent.
- Subjects > 18 years of age
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
- Histological or cytological diagnosis of adenocarcinoma of the colon or rectum.
Key exclusion criteria (16 listed)
- Any previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to this study.
- Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks before start of study medication.
- Uncontrolled hypertension. (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastinbevacizumab with the latest received cytotoxic regimen | Drug | bevacizumab-containing |
Primary outcome
Response rate
Time frame: Baseline and 6 weeks
Percentage of tumor regression
2 secondary outcomes
Overall survival
Time frame: From date of treatment until the date of death of any cause, assessed up to 48 months
Progression free survival
Time frame: From date of treatment until the date of disease progression, assessed up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Lan, Ph D principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Neoplasm and Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen 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 14 inclusion and 16 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 Sep 2020. 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 Jian Xiao, Ph D (86-20-38250745, xiaoj26@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2020.