Back to results

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

Primary Purpose

Gastric Adenocarcinoma

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Nanoparticle Albumin-Bound Paclitaxel

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring advanced, resistant to prior chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent form
Age 18-75 years;
Histologically or cytologically confirmed gastric cancer;
Advanced or recurrent, metastatic disease;
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
Life expectancy of at least 12 weeks;
At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
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;
Haematopoietic status:
- Absolute neutrophil count > 1.5 x 109/L,
- Platelet count > 90 x 109/L,
- Hemoglobin at least 9 g/dl,
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)
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；without malabsorption syndrome, or disease significantly affecting gastrointestinal function, such as ulcerative colitis and Crohn's disease;
Cardiovascular: Baseline LVEF 50% measured by echocardiography (ECHO) ;
Negative serum pregnancy test (For women of childbearing potential);Fertile patients must use effective contraception.

Exclusion Criteria:

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.

Sites / Locations

Lin Shen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nanoparticle Albumin-Bound Paclitaxel

Arm Description

The study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;

Outcomes

Primary Outcome Measures

adverse events

participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Objective response rate

CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

Secondary Outcome Measures

progression free survival

the follow-up visit of PFS will be performed every 6 weeks

overall survival of participants

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

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;

Full Information

NCT ID

NCT01336062

First Posted

April 4, 2011

Last Updated

May 17, 2015

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT01336062

Brief Title

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

Official Title

Phase Ib/IIa, Two-stage Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Adenocarcinoma

Keywords

advanced, resistant to prior chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nanoparticle Albumin-Bound Paclitaxel

Arm Type

Experimental

Arm Description

The study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;

Intervention Type

Drug

Intervention Name(s)

Nanoparticle Albumin-Bound Paclitaxel

Intervention Description

this study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;

Primary Outcome Measure Information:

Title

adverse events

Description

participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Time Frame

during the treatment in the hosptital,an expected average of 3 weeks

Title

Objective response rate

Description

CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

progression free survival

Description

the follow-up visit of PFS will be performed every 6 weeks

Time Frame

1 year

Title

overall survival of participants

Description

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

Time Frame

2 years

Title

biomarkers

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent form Age 18-75 years; Histologically or cytologically confirmed gastric cancer; Advanced or recurrent, metastatic disease; Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; Life expectancy of at least 12 weeks; At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors ) 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; Haematopoietic status: Absolute neutrophil count > 1.5 x 109/L, Platelet count > 90 x 109/L, Hemoglobin at least 9 g/dl, 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) 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；without malabsorption syndrome, or disease significantly affecting gastrointestinal function, such as ulcerative colitis and Crohn's disease; Cardiovascular: Baseline LVEF 50% measured by echocardiography (ECHO) ; Negative serum pregnancy test (For women of childbearing potential);Fertile patients must use effective contraception. Exclusion Criteria: 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.

Facility Information:

Facility Name

Lin Shen

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs