Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

NCT ID: NCT03779464

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-09-30

Brief Summary

A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

Detailed Description

A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

Conditions

Pancreatic Cancer; Nab-paclitaxel; Gemcitabine; S1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

S/nab

Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)

Group Type: EXPERIMENTAL

S1 or Gemcitabine

Intervention Type: DRUG

Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)

Gem/nab

Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)

Group Type: ACTIVE_COMPARATOR

S1 or Gemcitabine

Intervention Type: DRUG

Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)

Interventions

S1 or Gemcitabine

Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histological or cytological confirmation of pancreatic adenocarcinoma
• Distant metastatic or unresctable locally advanced diseases
• CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
• At least one lesion measurable by RECIST v1.1 criteria
• Life expectancy> 3 months
• No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
• No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
• Pain must be monitored before inclusion
• 18 years < age < 70
• Performance status: 0-1
• ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
• ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
• Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),
• creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
• Patient information and signature of informed consent

Exclusion Criteria

• Concurrent other effective treatment (including radiotherapy)
• Resectable patients
• Allergy history to other drugs in the same class patients with pregnancy or lactation
• Known severe internal medical diseases
• Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
• Immunocompromised patients, such as HIV positive
• Uncontrollable mental illness
• Other conditions the researchers considered ineligible for the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Tao Zhang

Chief of Gastrointestinal Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenyu lin, MD

Role: CONTACT

whxhlzy@hust.edu.cn

86-27-85871982

Tao Zhang, MD

Role: CONTACT

taozhangxh@hust.edu.cn

86-27-85871982

Facility Contacts

Yu Hu, MD

Role: primary

284409937@qq.com

027-85726114

References

Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

Reference Type: RESULT

PMID: 24131140 (View on PubMed)

Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.

Reference Type: RESULT

PMID: 23547081 (View on PubMed)

Xu Y, Guo X, Fan Y, Wang D, Wu W, Wu L, Liu T, Xu B, Feng Y, Wang Y, Lou W, Zhou Y. Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. Jpn J Clin Oncol. 2018 Jun 1;48(6):535-541. doi: 10.1093/jjco/hyy063.

Reference Type: RESULT

PMID: 29718363 (View on PubMed)

Other Identifiers

XHZL-001

Identifier Type: -

Identifier Source: org_study_id