Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients
- Conditions
- Gastric Adenocarcinoma
- Interventions
- Registration Number
- NCT01336062
- Lead Sponsor
- Peking University
- Brief Summary
Gastric cancer have poor prognosis and majority of patients resistant to 5-FU/DDP based first-line chemotherapy in China. There was no recommended second-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound Paclitaxel (Abraxane，ABI-007) has good convenience to use and been approved in breast cancer in many countries. The investigator then initiated a prospective phase Ib/IIa clinical trial with nab-paclitaxel plus TS-1 as the second-line treatment in advanced gastric cancer to observe the safety and efficacy.
- Detailed Description
This study is a two-stage design. Stage 1
The investigator should evaluate two recommend dose and tolerability of nab-paclitaxel plus S-1 after one course of treatment as 3+1 design:
nab-paclitaxel should be given intravenously on days 1 and 8 at a dose as follows, Treatment should be repeated every 3 weeks: Treatment arm A：125 mg /m2; Treatment arm B：100 mg /m2; Treatment arm C: 80 mg /m2; S-1 should be given orally twice a day as follows for 14 consecutive days, followed by a 1-week rest. Treatment should be repeated every 3 weeks. BSA \< 1.5 m2，40mg，bid;BSA ≥ 1.5 m2，50mg，bid.
The investigator should determine whether to continue the original regimen; compare the safety and pharmacokinetic results with original profile of combination therapy to select the best therapy programs (RD, recommended dose).
Stage 2 According to two-stage design (Simon,1989), re-entry subjects to the recommended dose group to a total of 25 valid cases. If 11 patients achieve response, then enter the second phase of total 66 patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
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Signed informed consent form
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Age 18-75 years;
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Histologically or cytologically confirmed gastric cancer;
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Advanced or recurrent, metastatic disease;
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Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
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Life expectancy of at least 12 weeks;
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At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
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Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence within 6 months after the end of systemic adjuvant treatment. The regimen must have contained fluorouracil(e.g. 5-FU,capecitabine) and/or cisplatin;
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Haematopoietic status:
- Absolute neutrophil count > 1.5 x 109/L,
- Platelet count > 90 x 109/L,
- Hemoglobin at least 9 g/dl,
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Hepatic status:
- Bilirubin ≤ 1.5 x upper limit of normal (ULN),
- AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis)
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Renal status:
- Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥40 mL/min;
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Able to swallow and retain oral medication；without malabsorption syndrome, or disease significantly affecting gastrointestinal function, such as ulcerative colitis and Crohn's disease;
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Cardiovascular: Baseline LVEF 50% measured by echocardiography (ECHO) ;
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Negative serum pregnancy test (For women of childbearing potential);Fertile patients must use effective contraception.
- Received any prior treatment including taxane or S-1;
- Concurrent systemic anti-cancer therapy (immunotherapy, biologic therapy, hormone therapy, etc ); received treatment with an investigational agent or participation in another therapeutic clinical trial within 4 weeks;
- Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater
- Symptomatic brain metastasis;
- Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;
- History of other malignancy. However, subjects with a past or current history of completely resected basal and squamous cell carcinoma of the skin or successfully treated in situ carcinoma of the cervix are eligible
- Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
- Active or uncontrolled infection;
- Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
- Pregnant or lactating women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel The study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;
- Primary Outcome Measures
Name Time Method adverse events during the treatment in the hosptital,an expected average of 3 weeks participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Objective response rate 6 weeks CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
- Secondary Outcome Measures
Name Time Method progression free survival 1 year the follow-up visit of PFS will be performed every 6 weeks
overall survival of participants 2 years OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
biomarkers 6 weeks If the tumour samples available, to identify the molecular characteristics(such as SPARK,ABCG2,β-Tubulin III,PDGFRA,etc) of responding tumours by immunohistochemical, FISH, genomic and proteomic analysis; To study biomarkers expression before and during therapy and establish correlations with clinical outcome and toxicity;
Trial Locations
- Locations (1)
Lin Shen
🇨🇳Beijing, Beijing, China