Metronomic Chemotherapy in Advanced Gastric Cancer

NCT ID: NCT02855788

Last Updated: 2016-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Gastric Cancer Locally Advanced Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

POLF regimen

Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

Group Type EXPERIMENTAL

Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

Intervention Type DRUG

metronomic chemotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

metronomic chemotherapy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Taxol, Eloxatin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. pathologically confirmed gastric cancer AJCC stage III or IV
2. measurable disease based on CT or endoscopy exam
3. non-surgical candidates or patients who declined surgery
4. non-radiation candidates or patients who declined radiation
5. patients who are able to sign informed consent
6. patients who are 2 weeks out and recovered from surgery
7. patients who have completed radiation to relieve obstructive symptoms
8. patient who previously received Oxaliplatin and 5-FU in other MTD regimens
9. adequate marrow function: neutrophil \>1000/ul, Hgb \>10g/dl, Plt\>50,000

Exclusion Criteria

1. allergic to any of the drugs involved
2. concurrent malignancies
3. severe co-morbidities of heart, lungs, kidneys and bone marrow
4. severe psychological disorder
5. severe malnutrition
6. difficult to heal or unhealed wound
7. ECOG performance status equal or over 3
8. uncontrolled complications from the malignancy
9. uncontrolled CNS metastasis
10. peripheral neuropathy grade 3 or above
11. pregnancy or breast feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seattle Integrative Cancer Center

UNKNOWN

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nick Chen

Visiting Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jie Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Nick N Chen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seattle Integrative Cancer Center

Jun Zhang, M.D.

Role: STUDY_DIRECTOR

Huashan Hospital

Zhongguang Luo, M.D.

Role: STUDY_DIRECTOR

Huashan Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seattle Integrative Cancer Center

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nick N Chen, M.D., Ph.D.

Role: CONTACT

206-588-1722

Jie Liu, M.D.

Role: CONTACT

021-5288236

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nick N Chen, M.D., Ph.D.

Role: primary

206-588-1722

Deb Ellifritt, BS

Role: backup

207-588-1722

Zhongguang Luo, M.D.

Role: primary

021-5288237

Jun Zhang, M.D.

Role: backup

021-5288237

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY2016-206

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.