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Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer (ITAGC)

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ClinicalTrials.gov Identifier: NCT02401971
Recruitment Status : Unknown
Verified September 2014 by Wang Jufeng, Zhengzhou University.
Recruitment status was:  Recruiting
First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Collaborators:
The First Affiliated Hospital of Zhengzhou University
Henan Provincial Hospital
Second Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Henan University of Science and Technology
Information provided by (Responsible Party):
Wang Jufeng, Zhengzhou University

Brief Summary:
Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Thalidomide Drug: CPT-11 Phase 4

Detailed Description:
This is a prospective, randomized, multi-center, controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide and CPT-11 in advanced gastric cancer. A total of 900 patients are planned to be enrolled into the study. Patients with diagnosis of advanced gastric cancer will be randomized into two groups, and be treated with thalidomide+ CPT-11 or CPT-11, respectively. The primary end point is time to progression (TTP), and the secondary end points include efficacy, overall survival (OS) and the occurrence of delayed diarrhea.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer : A Multicenter, Randomized, Controlled and Prospective Trial
Study Start Date : August 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Arm A (thalidomide+CPT-11)
Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles ,and oral thalidomide 100 mg/d qn. Maintenance therapy with thalidomide in the same dose is performed until disease progression.
Drug: Thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid

Drug: CPT-11
Given Ivgtt
Other Names:
  • Irinotecan hydrochloride
  • Campto
  • Camptosar
  • irinotecan
  • U-101440E

Experimental: Arm B (CPT-11)
Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles.
Drug: CPT-11
Given Ivgtt
Other Names:
  • Irinotecan hydrochloride
  • Campto
  • Camptosar
  • irinotecan
  • U-101440E




Primary Outcome Measures :
  1. time to progression(TTP) [ Time Frame: up to 2 months ]

Secondary Outcome Measures :
  1. complete response rate (CRR) for advanced gastric cancer [ Time Frame: up to 2 months ]
  2. overall survival (OS) [ Time Frame: up to 2 months ]


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

Inclusion Criteria:

  • 18y <Age<75y
  • Patients with histologically proven tumor focus will be eligible for this protocol
  • Measurable or assessable disease
  • At least 4 weeks since last chemotherapy ;chemotherapy regimens without Irinotecan
  • No hepatic, renal and hematopoietic dysfunction; no hemorrhage of digestive tract,obstructive jaundice, gastrointestinal perforation or obstruction
  • ECOG PS:0-2
  • Expected OS ≥ 3 months

Exclusion Criteria:

  • obstruction of digestive tract, thrombosis or other intolerant side effects during treatment

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): NCT02401971


Contacts
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Contact: Wang Jufeng 13783583966 13783583966@163.com

Locations
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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Wang Jufeng    13783583966@163.com    13783583966@163.com   
Sponsors and Collaborators
Wang Jufeng
The First Affiliated Hospital of Zhengzhou University
Henan Provincial Hospital
Second Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Henan University of Science and Technology
Investigators
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Study Chair: Wang Jufeng Henan Cancer Hospital
Principal Investigator: Qin Yanru The First Affiliated Hospital of Zhengzhou University
Principal Investigator: Zhou Yun Henan Provincial Hospital
Principal Investigator: Zhang Zhongmian Second Affiliated Hospital of Zhengzhou University
Principal Investigator: Guo Yanzhen The First Affiliated Hospital of Henan University of Science and Technology

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Responsible Party: Wang Jufeng, Master, Zhengzhou University
ClinicalTrials.gov Identifier: NCT02401971     History of Changes
Other Study ID Numbers: DREAM-002
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: September 2014

Keywords provided by Wang Jufeng, Zhengzhou University:
Thalidomide
Irinotecan
Second Line

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Thalidomide
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors