Anlotinib and Irinotecan for Ewing Sarcoma
Anlotinib and Irinotecan for Advanced Ewing Sarcoma After Failure of Standard Multimodal Therapy
1 other identifier
interventional
47
1 country
5
Brief Summary
The investigators explored the activity of anlotinib combined with irinotecan in patients with relapsed and metastatic Ewing Sarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2018
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2018
CompletedFirst Submitted
Initial submission to the registry
January 24, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 15, 2019
February 1, 2019
2 years
January 24, 2018
February 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose (MTD) (phase 1b)
evaluate the maximum tolerated dose (MTD) of combination therapy with irinotecan and anlotinib
12 months
Object response rate(ORR) at 12 weeks (phase 2)
complete response (CR) + partial response (PR) at 12 weeks
12 months
Secondary Outcomes (5)
Progression-free survival(PFS)
2 years
Overall survival(OS)
2 years
Adverse Effect
2 years
Quality of Life (QoL)
2 years
Pain management
2 years
Study Arms (2)
Anlotinib and Irinotecan(phase 1b)
EXPERIMENTALAnlotinib 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.
Anlotinib and Irinotecan(phase 2)
EXPERIMENTALAnlotinib 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
Anlotinib 12 or 8 mg/d po D1-14 q3w
Irinotecan 20 or 15mg/m\^2/d IV over 60 minutes on days 1-5 and 8-12, q3w
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Peking University First Hospital
Beijing, 100034, China
Peking University People's Hospital
Beijing, 100044, China
Peking University Shougang Hospital
Beijing, 100144, China
Peking University Third Hospital
Beijing, 100191, China
People's Liberation Army General Hospital
Beijing, 100853, China
Related Publications (1)
Dong S, Sun K, Xie L, Xu J, Sun X, Ren T, Huang Y, Yang R, Tang X, Yang F, Gu J, Guo W. Quality of life and Q-TWiST were not adversely affected in Ewing sarcoma patients treated with combined anlotinib, irinotecan, and vincristine: (Peking University People's Hospital Ewing sarcoma trial-02, PKUPH-EWS-02). Medicine (Baltimore). 2021 Dec 23;100(51):e28078. doi: 10.1097/MD.0000000000028078.
PMID: 34941047DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Guo, M.D, Ph.D
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Musculoskeletal Tumor Center
Study Record Dates
First Submitted
January 24, 2018
First Posted
January 31, 2018
Study Start
January 22, 2018
Primary Completion
February 1, 2020
Study Completion
December 1, 2020
Last Updated
February 15, 2019
Record last verified: 2019-02