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

NCT01336062 | Completed Phase 1

• 1 other identifier: NAB-PTX-GC
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma

Keywords

advanced; resistant to prior chemotherapy

Outcome Measures

Primary Outcomes (2)

• adverse events

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

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

• Objective response rate

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

  6 weeks

Secondary Outcomes (3)

• progression free survival

  1 year

• overall survival of participants

  2 years

• biomarkers

  6 weeks

Study Arms (1)

Nanoparticle Albumin-Bound Paclitaxel

EXPERIMENTAL

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

Drug: Nanoparticle Albumin-Bound Paclitaxel

Interventions

Nanoparticle Albumin-Bound Paclitaxel DRUG

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

Nanoparticle Albumin-Bound Paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Lin Shen

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Taxes

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRO.

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 15, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

CN (1)