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Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01336062
First Posted: April 15, 2011
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shen Lin, Peking University
  Purpose
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.

Condition Intervention Phase
Gastric Adenocarcinoma Drug: Nanoparticle Albumin-Bound Paclitaxel Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib/IIa, Two-stage Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients

Resource links provided by NLM:


Further study details as provided by Shen Lin, Peking University:

Primary Outcome Measures:
  • adverse events [ Time Frame: 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 [ Time Frame: 6 weeks ]
    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation


Secondary Outcome Measures:
  • progression free survival [ Time Frame: 1 year ]
    the follow-up visit of PFS will be performed every 6 weeks

  • overall survival of participants [ Time Frame: 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 [ Time Frame: 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;


Enrollment: 19
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nanoparticle Albumin-Bound Paclitaxel
The study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;
Drug: Nanoparticle Albumin-Bound Paclitaxel
this study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent form
  2. Age 18-75 years;
  3. Histologically or cytologically confirmed gastric cancer;
  4. Advanced or recurrent, metastatic disease;
  5. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
  6. Life expectancy of at least 12 weeks;
  7. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
  8. 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;
  9. Haematopoietic status:

    • Absolute neutrophil count > 1.5 x 109/L,
    • Platelet count > 90 x 109/L,
    • Hemoglobin at least 9 g/dl,
  10. 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)
  11. Renal status:

    - Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥40 mL/min;

  12. Able to swallow and retain oral medication;without malabsorption syndrome, or disease significantly affecting gastrointestinal function, such as ulcerative colitis and Crohn's disease;
  13. Cardiovascular: Baseline LVEF 50% measured by echocardiography (ECHO) ;
  14. Negative serum pregnancy test (For women of childbearing potential);Fertile patients must use effective contraception.

Exclusion Criteria:

  1. Received any prior treatment including taxane or S-1;
  2. 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;
  3. Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater
  4. Symptomatic brain metastasis;
  5. 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;
  6. 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
  7. Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
  8. Active or uncontrolled infection;
  9. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
  10. Pregnant or lactating women.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336062


Locations
China, Beijing
Lin Shen
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
  More Information

Responsible Party: Shen Lin, PRO., Peking University
ClinicalTrials.gov Identifier: NCT01336062     History of Changes
Other Study ID Numbers: NAB-PTX-GC
First Submitted: April 4, 2011
First Posted: April 15, 2011
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Shen Lin, Peking University:
advanced
resistant to prior chemotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action