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Metronomic Chemotherapy in Advanced Gastric Cancer

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Fudan University

Status and phase

Unknown
Phase 2

Conditions

Locally Advanced Gastric Cancer
Metastatic Gastric Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02855788
KY2016-206

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

POLF regimen
Experimental group
Description:
Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
Treatment:
Drug: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

Trial contacts and locations

2

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Central trial contact

Jie Liu, M.D.; Nick N Chen, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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