Study of the Combination of Apatinib and POF

Gastric Adenocarcinoma Clinical Trial

Official title:

Phase II Study of the Combination of Apatinib and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03707639
• Other study ID #: FNF011
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2018
• Est. completion date: November 2020

Study information

• Verified date: October 2018
• Source: Fujian Cancer Hospital
• Contact: Rongbo Lin
• Phone: 13705919382
• Email: rongbo_lin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators conducted the dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Now we are going to start a phase 2 trial with apatinib 500mg + POF as first-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: November 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.

No previous treatment with chemotherapy or radiation therapy. Ability to take medications orally. With measurable lesions. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of =100g/L (without blood transfusion during 14 days); a leucopenia count of =4.0×109/L; a platelet count of =100×109/L; a total bilirubin (TBil) of =1.5 upper normal limitation (UNL); a creatinine (Cr) of = 1.5 UNL; a creatinine clearance rate = 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of =2.5 UNL or =5 UNL in case of liver metastasis.

Life expectancy =3 months. With normal electrocardiogram results and no history of congestive heart failure.

Without bleeding and thrombosis disease. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each = 1.5 x ULN.

Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.

With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.

Patients with brain or central nervous system metastases, including leptomeningeal disease.

Pregnant (positive pregnancy test) or breast feeding. Serious, non-healing wound, ulcer, or bone fracture. Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.

History of a stroke or CVA within 6 months. Clinically significant peripheral vascular disease. Inability to comply with study and/or follow-up procedures. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Drug:
• Apatinib
Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
• POF
The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.

Locations

Country	Name	City	State
China	Rongbo Lin	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	According to RECIST 1.1	From enrollment to 3 months after treatment
Secondary	Progression-free survival	The length of time from enrollment until the time of progression of disease	From enrollment to progression of disease. Estimated about 12 months.
Secondary	Overall survival	The length of time from enrollment until the time of death	From enrollment to death of patients. Estimated about 18 months
Secondary	Toxicity According to NCI CTCAE 4.03 criteria	According to NCI CTCAE 4.03 criteria	From enrollment to 3 months after treatment