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Trial Title:
Efficacy and Safety Study of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients
NCT ID:
NCT01641783
Condition:
Gastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Conditions: Keywords:
advanced
paclitaxel
capecitabine
first line therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
nanoparticle Albumin-Bound paclitaxel
Description:
nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv
Arm group label:
nanoparticle Albumin-bound paclitaxel
Other name:
ABI-007
Summary:
Gastric cancer remains one of the major causes of cancer deaths around the
world,especially in Asia. For advanced gastric cancer,even if treated with
chemotherapy,the prognosis is still poor, so the investigators urgently need an effective
strategy to treat advanced gastric cancer, however, there was no recommended First-line
chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer.
Nanoparticle Albumin-Bound (Nab) Paclitaxel (Abraxane，ABI-007) with high effectiveness
and low toxicity had been approved in breast cancer as first-line chemotherapy in many
countries. The investigator then initiated a prospective phase II clinical trial with
Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer
to observe the efficacy and safety.
Detailed description:
A single arm,open,phase II study of Nab-Paclitaxel plus Capecitabine as the first-line
treatment in advanced gastric cancer.
Nab-Paclitaxel should be given intravenously on days 1 and 8 at a dose as follows.
Treatment should be repeated every 3 weeks:Nab-Paclitaxel:125 mg/m2; Capecitabine 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. Capecitabine:1000mg/m2,twice daily
(bid).
If applicable,the value of response and prognosis predictive factors are expected to be
identified.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- signed informed consent form;
- histologically or cytologically confirmed gastric cancer;
- Age 18-75 years;
- Advanced or recurrent, metastatic disease;
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
- Life expectancy of at least 12 weeks;
- At least have one measurable disease(according to RECIST, Response Evaluation
Criteria in Solid Tumors );
- no prior history of chemotherapy or beyond 6 months after the end of systemic
adjuvant treatment;
- Haematopoietic status:
- Absolute neutrophil count > 1.5 x 109/L;
- Platelet count > 90 x 109/L;
- Hemoglobin at least 90g/l;
- 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);
- ALP ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver or bone
metastasis);
- serum albumin ≥ 30g/L;
- Renal status:
- Creatinine ≤ 1.5 times ULN or calculated creatinine clearance, using the
Cockcroft-Gault formula, ≥ 40 mL/min;
- Able to swallow and retain oral medication;
Exclusion Criteria:
- 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;
- dementia, altered mental status, or any psychiatric condition that would prevent the
understanding or rendering of ICF;
- active or uncontrolled infection;
- pregnant or lactating women;
- dysmetabolism with nanoparticle Albumin-bound paclitaxel or Capecitabine
- unable to swallow and retain oral medication,intestinal Obstruction,alimentary tract
hemorrhage
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 2012
Completion date:
December 2013
Lead sponsor:
Agency:
Yanqiao Zhang
Agency class:
Other
Source:
The Third Affiliated Hospital of Harbin Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01641783
