Efficacy and Safety Study of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients
This study is not yet open for participant recruitment.
Verified July 2012 by The Third Affiliated Hospital of Harbin Medical University
Sponsor:
Yanqiao Zhang
Information provided by (Responsible Party):
Yanqiao Zhang, The Third Affiliated hospital of Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01641783
First received: July 11, 2012
Last updated: July 13, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Adenocarcinoma |
Drug: nanoparticle Albumin-Bound paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | To Evaluate the Efficacy and Safety of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients:a Phase II Single Center Prospective Clinical Trial |
Resource links provided by NLM:
Further study details as provided by The Third Affiliated Hospital of Harbin Medical University:
Primary Outcome Measures:
- progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]the follow-up visit of PFS will be performed every 6 weeks
Secondary Outcome Measures:
- objective response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]CT/MRI/Ultrasound will be performed every 2 cycles of treatment for efficacy evaluation
- overall survival of participants [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]To identify the molecular biomarkers(such as SPARK,β-Tubulin III,caveolin,etc)by immunohistochemical and western-bloting before and during therapy,to study the biomarkers correlations with clinical outcome and toxicity.
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: nanoparticle Albumin-bound paclitaxel
evaluate one dose level of nab-paclitaxel:125mg/m2
|
Drug: nanoparticle Albumin-Bound paclitaxel
nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv
Other Name: ABI-007
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641783
Contacts
| Contact: Yanqiao Zhang, M.D. | 86-0451-86298222 | yanqiaozhang@126.com |
| Contact: Ming yang, Master | 86-0451-86298281 | yangming_0517@163.com |
Sponsors and Collaborators
Yanqiao Zhang
Investigators
| Principal Investigator: | Yanqiao Zhang, M.D. | Harbin Medical University |
More Information
No publications provided
| Responsible Party: | Yanqiao Zhang, Principal Investigator, The Third Affiliated hospital of Harbin Medical University |
| ClinicalTrials.gov Identifier: | NCT01641783 History of Changes |
| Other Study ID Numbers: | YL2012-03 |
| Study First Received: | July 11, 2012 |
| Last Updated: | July 13, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by The Third Affiliated Hospital of Harbin Medical University:
|
advanced paclitaxel capecitabine first line therapy |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Stomach Diseases Paclitaxel Capecitabine Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 16, 2013