Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 89 of 2832 for:    Pancreatic Cancer

Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03415802
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Aiping Zhou, Chinese Academy of Medical Sciences

Brief Summary:
Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.

Condition or disease Intervention/treatment Phase
Advanced Pancreatic Cancer Drug: Nab-paclitaxel and S-1 Phase 2

Detailed Description:

Gemcitabine has been approved as the standard chemotherapy for advanced pancreatic cancer since 1996, but the efficacy is extremely limited by a response rate of 6-8%, and median survival of 5.5-7 months. However, Gemcitabine-based combination treatments fail to transcend GEM monotherapy on overall survival, including GEM + 5-Fu [10], GEM + Oxaliplatin[11], and GEM + Irinotecan [12] and GEM + Cisplatin [13] (7-8) . Until 2011, Conroy et al.[15] reported that FOLFIRINOX solutions significantly improved ORR (31.6% vs 9%, P=0.0008), PFS (6.4 vs. 3.3 months, P<0.0001) and OS (11.1 vs. 6.8 months, P<0.001) than GEM single-agent, but the significant increase of grade 3/4 adverse reactions, to some extent, limited its wide application. Therefore, it is necessary to continue to explore effective and safe chemotherapy of advanced pancreatic cancer.

Nab-Paclitaxel was approved by FDA for advanced pancreatic cancer in September 2013. S-1 has demonstrated potential value in the treatment of advanced pancreatic cancer as a new compound oral 5-FU(4-5) and has been approved for pancreatic cancer treatment in Japan.

We conducted a single arm, prospective, phase II study in our center on the first-line treatment of advanced pancreatic cancer with nab-Paclitaxel and S-1 to investigate the efficacy and safety of the combination regimen.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer: A Pilot Single Arm Phase II Study
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Nab-paclitaxel Plus S-1
Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w)
Drug: Nab-paclitaxel and S-1
Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)
Other Name: Abraxane,Tegafur, Gimeracil and Oteracil Porassium




Primary Outcome Measures :
  1. Objective response rate(ORR) [ Time Frame: 6 month ]
    CR+PR was defined as objective response rate (ORR)


Secondary Outcome Measures :
  1. DCR [ Time Frame: 6 month ]
    CR+PR+SD was defined as disease control rate (DCR)

  2. PFS [ Time Frame: 6 month ]
    From date of randomization until date of first documented PD, date of death

  3. OS [ Time Frame: 1 year ]
    From date of randomization until date of death

  4. Safety profile: Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer [ Time Frame: 1 year ]
    Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age, years: 18-75
  • Histologically and cytologically confirmed advanced pancreatic cancer , inresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
  • Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
  • Laboratory examination within 14 days before entering the study should meet following requirements: ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN(with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
  • Both male and female subjects of potential fertility have to agree effective birth control during the entire study
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415802


Contacts
Layout table for location contacts
Contact: Aiping Zhou, Doctor +86 13691161998 zhouap1825@126.com

Locations
Layout table for location information
China
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, China
Contact: Aiping Zhou, Doctor    +86 13691161998    zhouap1825@126.com   
Sponsors and Collaborators
Aiping Zhou
Investigators
Layout table for investigator information
Principal Investigator: Aiping Zhou, Doctor National Cancer Center/Cancer Hospital, China

Layout table for additonal information
Responsible Party: Aiping Zhou, Chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03415802     History of Changes
Other Study ID Numbers: CH-GI-062
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aiping Zhou, Chinese Academy of Medical Sciences:
Nab-Paclitaxel
S-1
Advanced Pancreatic Cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action