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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01336062
First received: April 4, 2011
Last updated: June 29, 2011
Last verified: March 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Peking University:

Primary Outcome Measures:
  • adverse events [ Time Frame: during the treatment in the hosptital,an expected average of 3 weeks ] [ Designated as safety issue: Yes ]
    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • Objective response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation


Secondary 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

  • 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 ]
    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;


Estimated Enrollment: 72
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336062

Contacts
Contact: Lin Shen, MD 86-10-88196175 lin100@medmail.com.cn
Contact: Jifang Gong, MD 86-10-88196088 gongjifang@gmail.com

Locations
China, Beijing
Lin Shen Recruiting
Beijing, Beijing, China, 100142
Contact: Jifang Gong, MD    86-10-88196088    gongjifang@gmail.com   
Principal Investigator: Lin Shen, MD         
Sponsors and Collaborators
Peking University
  More Information

No publications provided

Responsible Party: Lin Shen, Department of GI oncology,Peking University, School of Oncology
ClinicalTrials.gov Identifier: NCT01336062     History of Changes
Other Study ID Numbers: NAB-PTX-GC
Study First Received: April 4, 2011
Last Updated: June 29, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by 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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014