Clinical trial NCT02090153: Study of S-1 Plus LV for Advanced Gastric Cancer
Official title: Phase II Study of S-1 Plus Leucovorin (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic and Recurrent Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Advance Gastric Cancer,
S-1 plus leucovorin,
ORR,
OS,
TTP,
TTF,
Adverse events,
Pharmacokinetics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Taiho Pharmaceutical Co., Ltd.
First posted: 2014-03-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.

Detailed description: Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)\<1.25 m2), 50 mg (1.25≤BSA\<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.

Eligibility criteria: Inclusion Criteria:

* histologically conﬁrmed metastatic or recurrent gastric cancer
* with at least one measurable lesion by RECIST criteria
* an age of ≥ 18
* adequate oral intake
* no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if ﬁnished 6 months before enrollment)
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* adequate bone marrow function, hepatic function and renal functions

Exclusion Criteria:

* a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1
* serious concomitant conditions (severe heart disease, pulmonary ﬁbrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeﬁciency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)
* extensive bone metastasis, brain metastasis or meningeal metastasis
* another synchronous cancer
* surgery within 3 weeks before enrollment
* participating in other clinical studies
* women who were or to be pregnant, nursing infants, and men who were to conceive children

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 year
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 1-1.5 years
measure: Overall survival (OS)
timeFrame: 1-2.5 years
measure: Time to treatment failure (TTF)
timeFrame: 1 year
measure: Disease control rate
timeFrame: 1 year
measure: Adverse Events (AEs)
timeFrame: 2 year
Other outcomes:
Locations:
city: Gaungzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: SunYat-sen University Cancer Center
name: Ruihua Xu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koizumi W, Boku N, Yamaguchi K, Miyata Y, Sawaki A, Kato T, Toh Y, Hyodo I, Nishina T, Furuhata T, Miyashita K, Okada Y. Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer. Ann Oncol. 2010 Apr;21(4):766-771. doi: 10.1093/annonc/mdp371. Epub 2009 Oct 14.
citation: He MM, Zhang DS, Wang F, Wang ZX, Yuan SQ, Wang ZQ, Luo HY, Ren C, Qiu MZ, Jin Y, Wang DS, Chen DL, Zeng ZL, Li YH, He YY, Hao YT, Guo P, Wang FH, Zeng YX, Xu RH. Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway. Cancer Chemother Pharmacol. 2017 Jan;79(1):69-79. doi: 10.1007/s00280-016-3209-1. Epub 2016 Dec 2.