Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anlotinib and Irinotecan for Ewing Sarcoma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416517
Recruitment Status : Unknown
Verified February 2019 by GUO WEI, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : January 31, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
GUO WEI, Peking University People's Hospital

Tracking Information
First Submitted Date  ICMJE January 24, 2018
First Posted Date  ICMJE January 31, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE January 22, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2019)
  • Maximum tolerated dose (MTD) (phase 1b) [ Time Frame: 12 months ]
    evaluate the maximum tolerated dose (MTD) of combination therapy with irinotecan and anlotinib
  • Object response rate(ORR) at 12 weeks (phase 2) [ Time Frame: 12 months ]
    complete response (CR) + partial response (PR) at 12 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
Object response rate(ORR) at 12 weeks [ Time Frame: 12 months ]
complete response (CR) + partial response (PR) at 12 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Progression-free survival(PFS) [ Time Frame: 2 years ]
    Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
  • Overall survival(OS) [ Time Frame: 2 years ]
    Calculated from the date of treatment start until last follow-up or death, whichever comes first.
  • Adverse Effect [ Time Frame: 2 years ]
    Adverse effect measured by CTCAE v.4 (Common Terminology Criteria for Adverse Events)
  • Quality of Life (QoL) [ Time Frame: 2 years ]
    Quality of Life measured by EORTC QLQ(quality of life questionnair) C-30 for adults or PedsQL3.0 for children.
  • Pain management [ Time Frame: 2 years ]
    Pain management measured by Visual Analog Score for pain.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anlotinib and Irinotecan for Ewing Sarcoma
Official Title  ICMJE Anlotinib and Irinotecan for Advanced Ewing Sarcoma After Failure of Standard Multimodal Therapy
Brief Summary The investigators explored the activity of anlotinib combined with irinotecan in patients with relapsed and metastatic Ewing Sarcoma.
Detailed Description After standard multimodal therapy, the prognosis of relapsed and metastatic Ewing Sarcoma is dismal and unchanged over the last decades.Thus, the investigators explored the activity of anlotinib combined with irinotecan in patients with relapsed and metastatic Ewing Sarcoma after the failure of first-line chemotherapy with doxorubicin, vincristine, cyclophosphamide, ifosphamide and etoposide.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ewing's Tumor Metastatic
Intervention  ICMJE
  • Drug: Anlotinib
    Anlotinib 12 or 8 mg/d po D1-14 q3w
    Other Name: AL3818
  • Drug: Irinotecan
    Irinotecan 20 or 15mg/m^2/d IV over 60 minutes on days 1-5 and 8-12, q3w
    Other Name: Camptosar
Study Arms  ICMJE
  • Experimental: Anlotinib and Irinotecan(phase 1b)
    Anlotinib 12 or 8 mg/d PO on days 1-14 q3w. Irinotecan 20 or 15mg/m^2/d over 60 minutes on days 1-5 and 8-12 q3w. Vincristine 1.4mg/m^2/d IV on days 1,8 q3w. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Anlotinib
    • Drug: Irinotecan
  • Experimental: Anlotinib and Irinotecan(phase 2)
    Anlotinib 12 or 8 mg/d PO on days 1-14 q3w. Irinotecan 20 or 15 mg/m^2/d IV over 60 minutes on days 1-5 and 8-12 q3w. The final dose of anlotinib and irinotecan depends on the result from previous phase Ib study. Vincristine 1.4mg/m^2/d IV on days 1,8 q3w. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Anlotinib
    • Drug: Irinotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 13, 2019)
47
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2018)
22
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed Ewing sarcoma.
  • Evidence of Ewing sarcoma translocation by fluorescence in situ hybridization (FISH) or real-time polymerase chain reaction (RT-PCT).
  • Recurrent or refractory tumors with no known curative treatment options according to the judgment of the investigator.
  • Prior treatment consisted of standard Ewing Sarcoma chemotherapy agents including doxorubicin, vincristine, cyclophosphamide, ifosfamide and etoposide; metastatic relapsed and unresectable progressive disease (PD);
  • Life expectancy of ≥ 3 months.
  • Eastern Cooperative Oncology Group performance status 0-1
  • Measurable disease on CT or MRI by RECIST 1.1.
  • Adequate organ function.
  • Time elapsed from previous therapy must be ≥ 3 weeks for systemic therapy, ≥ 2 weeks for radiation therapy or major surgery.
  • Patients who have undergone autologous hematopoietic stem cell transplantation are eligible once they have recovered from all toxicities from therapy.
  • Patients who have received allogeneic hematopoietic stem cell transplantation will be eligible 6 months after the procedure provided there is no evidence of active graft-versus-host disease and immunosuppressive treatment has been discontinued for at least 30 days.
  • Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of central nervous system metastatic disease, have been off glucocorticoids for at least 4 weeks, have no overt evidence of neurological deficit and are ≥ 6 weeks from completion of brain irradiation.
  • Females of childbearing potential as well as males and their partners must agree to use an effective form of contraception during the study and for 6 months following the last dose of study medication.

Exclusion Criteria:

  • Clinically significant unrelated illness which would, in the judgment of the treating physician, compromise the patient's ability to tolerate the investigational agent or be likely to interfere with the study procedures or results.
  • Prior treatment consisted of anlotinib, any other antiangiogenic TKIs, or irinotecan.
  • Patients with baseline corrected QT interval(QTc) > 480 msec.
  • Known hypersensitivity reaction to anlotinib or any of its components, and irinotecan or any of its components.
  • Concomitant use of any other investigational or anticancer agent(s).
  • Pregnant patients or patients who are breast feeding. Subjects capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months since final menstrual period) must have a negative pregnancy test within 7 days prior to first dose.
  • Inability to swallow capsules or water.
  • Other clinically significant malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.
  • Known persistent (> 4 weeks) ≥ Grade 2 neutropenia, ≥ Grade 2 thrombocytopenia or > Grade 3 anemia from prior cancer therapy.
  • Other kinds of malignant tumors at the same time.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03416517
Other Study ID Numbers  ICMJE PKUPH-EWS-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party GUO WEI, Peking University People's Hospital
Study Sponsor  ICMJE Peking University People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei Guo, M.D, Ph.D Peking University People's Hospital
PRS Account Peking University People's Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP