Metastatic Gastric CancerPhase 2NCT02855788
Metronomic Chemotherapy in Advanced Gastric Cancer
A Phase 2 study testing Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly in people with Metastatic Gastric Cancer and Locally Advanced Gastric Cancer, run by Huashan Hospital at 2 sites in 2 countries.
Trial summary
phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Gastric Cancer, Locally Advanced Gastric Cancer
- What is being tested?
- Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2015to Oct 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically confirmed gastric cancer AJCC stage III or IV
- measurable disease based on CT or endoscopy exam
- non-surgical candidates or patients who declined surgery
- non-radiation candidates or patients who declined radiation
- patients who are able to sign informed consent
- patients who are 2 weeks out and recovered from surgery
Show all 9Show fewer
- patients who have completed radiation to relieve obstructive symptoms
- patient who previously received Oxaliplatin and 5-FU in other MTD regimens
- adequate marrow function: neutrophil >1000/ul, Hgb >10g/dl, Plt>50,000
Who cannot join
- allergic to any of the drugs involved
- concurrent malignancies
- severe co-morbidities of heart, lungs, kidneys and bone marrow
- severe psychological disorder
- severe malnutrition
- difficult to heal or unhealed wound
Show all 11Show fewer
- ECOG performance status equal or over 3
- uncontrolled complications from the malignancy
- uncontrolled CNS metastasis
- peripheral neuropathy grade 3 or above
- pregnancy or breast feeding
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Seattle Integrative Cancer Center
Seattle, Washington, 98188
Nick N Chen, M.D., Ph.D., 206-588-1722, nicknchenmd@gmail.com
Deb Ellifritt, BS, 207-588-1722, debe@siccwa.com
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Zhongguang Luo, M.D., 021-5288237, luozg8@126.com
Jun Zhang, M.D., 021-5288237, archsteed@163.com
About this study
Official title: Phase II Study of Metronomic Chemotherapy Using POLF Regimen in the Treatment of Advanced Gastric Cancer
phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer
Read the detailed description
About 80% of patients with advanced gastric cancer are diagnosed at an advanced stage with limited treatment options including systemic chemotherapy with or without radiation. Commonly used maximally tolerated dose (MTD) chemotherapy such as DCT, ECF, FOLFOX regimens induce responses in the range of 20 to 50% with median survival in the range of 10 to 12 months. Metronomic chemotherapy has been found to have more consistent anti-tumor effects through anti-angiogenic and immunomodulating effects. Preliminary clinical studies of weekly POLF have found very encouraging clinical activities and low overall toxicities in pancreatic cancer and gastric cancer. Here we conduct a formal clinical trial to determine the clinical efficacy and side effect profiles of this regimen in patients with advanced gastric cancer.
- Being tested
- Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
- Keywords
- gastric cancer, gastroesophageal cancer, metastatic, advanced
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weeklyDrug
Also called Taxol, Eloxatin
metronomic chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| POLF regimen | Experimental | Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly Receives: Drug: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
based on Recist 1.1
Measured: 3 months
Secondary outcomes (3)
adverse events
based on NCI-CTC v.2
Measured: 2 years
progression free survival
median
Measured: 2 years
overall survival
median
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionJul 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Integrative Cancer Center
- Responsible party
- Principal investigator, Nick Chen, Huashan Hospital
- Investigators
- Jie Liu, M.D., Principal investigator, Huashan HospitalNick N Chen, M.D., Ph.D., Principal investigator, Seattle Integrative Cancer CenterJun Zhang, M.D., Study director, Huashan HospitalZhongguang Luo, M.D., Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855788
- Sponsor's protocol ID
- KY2016-206
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Metronomic Chemotherapy Using POLF Regimen in the Treatment of Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02855788
- Acronym / sponsor ID
- KY2016-206
- Keywords
- gastric cancer, gastroesophageal cancer, metastatic, advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Seattle Integrative Cancer Center
- Study start
- May 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 4 Aug 2016 (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.
phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer
Detailed description
About 80% of patients with advanced gastric cancer are diagnosed at an advanced stage with limited treatment options including systemic chemotherapy with or without radiation. Commonly used maximally tolerated dose (MTD) chemotherapy such as DCT, ECF, FOLFOX regimens induce responses in the range of 20 to 50% with median survival in the range of 10 to 12 months. Metronomic chemotherapy has been found to have more consistent anti-tumor effects through anti-angiogenic and immunomodulating effects. Preliminary clinical studies of weekly POLF have found very encouraging clinical activities and low overall toxicities in pancreatic cancer and gastric cancer. Here we conduct a formal clinical trial to determine the clinical efficacy and side effect profiles of this regimen in patients with advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POLF regimen | Experimental | Drug: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weeklyPaclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- pathologically confirmed gastric cancer AJCC stage III or IV
- measurable disease based on CT or endoscopy exam
- non-surgical candidates or patients who declined surgery
- non-radiation candidates or patients who declined radiation
- patients who are able to sign informed consent
Key exclusion criteria (11 listed)
- allergic to any of the drugs involved
- concurrent malignancies
- severe co-morbidities of heart, lungs, kidneys and bone marrow
- severe psychological disorder
- severe malnutrition
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 |
|---|---|---|
| Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weeklyAlso: Taxol, Eloxatinmetronomic chemotherapy | Drug | POLF regimen |
Primary outcome
response rate
Time frame: 3 months
based on Recist 1.1
3 secondary outcomes
adverse events
Time frame: 2 years
progression free survival
Time frame: 2 years
overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Individual participant dataSharing planned: Yes
Related trials for Metastatic Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 2
Avutometinib and Defactinib in Diffuse Gastric Cancer
Gastric Cancer, Stomach Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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.
Jie Liu, M.D. principal investigator
Huashan Hospital
Nick N Chen, M.D., Ph.D. principal investigator
Seattle Integrative Cancer Center
Jun Zhang, M.D. study director
Huashan Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly in people with Metastatic Gastric Cancer and Locally Advanced Gastric Cancer, run by Huashan Hospital at 2 sites in 2 countries.
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 11 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 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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 Nick N Chen, M.D., Ph.D. (206-588-1722, nicknchenmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 3 months). 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 4 Aug 2016.