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

• Sponsor: Wuhan Union Hospital, China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03779464
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer; Nab-paclitaxel; Gemcitabine; S1	Drug: S1 or Gemcitabine	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
• Anticipated Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Dec 30, 2020
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Drug: 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)
Active Comparator: Gem/nab Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)	Drug: 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)

Outcome Measures

Primary Outcome Measures

1. PFS [6 month]

   progression-free survival

Secondary Outcome Measures

1. OS [1 year]

   overall survival

2. ORR [6 month]

   objective response rate

3. DCR [6 month]

   CR+PR+SD was defined as disease control rate (DCR)

4. Safety profile :Adverse events of nab-Paclitaxel plus S-1 [1 year]

   Adverse events of nab-Paclitaxel plus S-1

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022

Sponsors and Collaborators

• Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tao Zhang, Chief of Gastrointestinal Oncology, Wuhan Union Hospital, China
• ClinicalTrials.gov Identifier: NCT03779464
• Other Study ID Numbers: XHZL-001
• First Posted: Dec 19, 2018
• Last Update Posted: Jul 8, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tao Zhang, Chief of Gastrointestinal Oncology, Wuhan Union Hospital, China: pancreatic cancer; nab-paclitaxel; gemcitabine; S1
• Additional relevant MeSH terms: Adenocarcinoma; Pancreatic Neoplasms; Gemcitabine

Study Results

No Results Posted as of Jul 8, 2019