NCT02401971

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for phase_4 gastric-cancer

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_4 gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 30, 2015

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

February 25, 2015

Last Update Submit

March 27, 2015

Conditions

Gastric Cancer

Keywords

ThalidomideIrinotecanSecond Line

Outcome Measures

Primary Outcomes (1)

  • time to progression(TTP)

    up to 2 months

Secondary Outcomes (2)

  • complete response rate (CRR) for advanced gastric cancer

    up to 2 months

  • overall survival (OS)

    up to 2 months

Study Arms (2)

Arm A (thalidomide+CPT-11)

EXPERIMENTAL

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: ThalidomideDrug: CPT-11

Arm B (CPT-11)

EXPERIMENTAL

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

Interventions

ThalidomideDRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid
Arm A (thalidomide+CPT-11)
CPT-11DRUG

Given Ivgtt

Also known as: Irinotecan hydrochloride, Campto, Camptosar, irinotecan, U-101440E
Arm A (thalidomide+CPT-11)Arm B (CPT-11)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • y \<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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ThalidomideIrinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCamptothecinAlkaloids

Study Officials

  • Wang Jufeng

    Henan Cancer Hospital

    STUDY CHAIR

  • Qin Yanru

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

  • Zhou Yun

    Henan Provincial People's 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Jufeng

CONTACT

1378358396613783583966@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 30, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2018

Last Updated

March 30, 2015

Record last verified: 2014-09

Locations

CN(1)