Phase I Study of Axitinib in Combination with Cisplatin and Capecitabine in Patients with Previously Untreated Advanced Gastric Cancer / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment
;
: 687-696, 2015.
Article
in English
| WPRIM
| ID: wpr-74295
ABSTRACT
PURPOSE:
This phase I trial evaluated the question of whether the standard starting dose of axitinib could be administered in combination with therapeutic doses of cisplatin/capecitabine in patients with previously untreated advanced gastric cancer, and assessed overall safety, pharmacokinetics, and preliminary antitumor activity of this combination. MATERIALS ANDMETHODS:
Patients in dose level (DL) 1 received axitinib 5 mg twice a day (days 1 to 21) with cisplatin 80 mg/m2 (day 1) and capecitabine 1,000 mg/m2 twice a day (days 1 to 14) in 21-day cycles. Maximum tolerated dose (MTD) was the highest dose at which 5 consecutive days of missed axitinib due to thrombocytopenia. DL1 was established as the MTD, since higher DL cohorts were not planned. Common grade 3/4 non-hematologic adverse events in 22 patients treated at DL1 included hypertension (36.4%) and decreased appetite and stomatitis (18.2% each). Cisplatin/capecitabine slightly increased axitinib exposure; axitinib decreased capecitabine and 5-fluorouracil exposure. Eight patients (36.4%) each had partial response or stable disease. Median response duration was 9.1 months; median progression-free survival was 3.8 months.CONCLUSION:
In patients with advanced gastric cancer, standard doses of axitinib plus therapeutic doses of cisplatin and capecitabine could be administered in combination. Adverse events were manageable.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Appetite
/
Stomach Neoplasms
/
Stomatitis
/
Thrombocytopenia
/
Pharmacokinetics
/
Cohort Studies
/
Cisplatin
/
Aortic Aneurysm, Abdominal
/
Disease-Free Survival
/
Maximum Tolerated Dose
Type of study:
Etiology study
/
Incidence study
/
Observational study
/
Risk factors
Limits:
Humans
Language:
English
Journal:
Cancer Research and Treatment
Year:
2015
Type:
Article
Similar
MEDLINE
...
LILACS
LIS