Soft Tissue SarcomaPhase 2NCT01812018
Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma
A Phase 2 study testing Endostar, Gemcitabine and Docetaxel in people with Soft Tissue Sarcoma, run by Peng Yuan at 1 site in China.
Trial summary
The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Endostar, Gemcitabine and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-70 years, male or female.
- ECOG performance status <=2.
- Life expectancy >= 3 months.
- Histologically or cytologically confirmed soft tissue sarcoma (GIST excluded).
- Patients must have had a prior anthracycline and/or ifosfamide in either the adjuvant or metastatic setting but not more than one regimen.
- At least one measurable pulmonary metastasis tumor lesions according to RECIST 1.1 criteria.
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- Laboratory values: Hemoglobin (Hb) >= 90 g/L and no blood transfusion within 14 days, Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, Platelet (Plt)>= 80 x 10^9/L, Total Bilirubin (Tbil)=< 1.5 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN or =< 5 x ULN if liver metastases are present, Serum creatinine (Cr) =< 1.0 x ULN, Endogenous creatinine clearance (Ccr)> 50 mL/min (Cockcroft-Gault).
- Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and be willing to use effective contraception during study and for 8 weeks after last IMP administration.
- Willingness to participate in study and sign informed consent form.
Who cannot join
- Females who are pregnant or breastfeeding or have Childbearing potential unwilling to use effective contraception.
- Prior therapy with Gemcitabine, Docetaxel and Endostar.
- Subjects participating in other clinical trials within 4 weeks before enrollment.
- Accompanied by rapid progress of organ invasions, e.g.lesion areas are great than one half of liver or lung or have liver dysfunction.
- Uncontrolled central nervous system disorder or psychiatric illness.
- Current, serious, clinically significant cardiac arrhythmias, symptomatic congestive heart failure, myocardial infarction before enrollment.
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- Patients with abnormal bone marrow function: ANC < 1.5 x 10^9/L, Plt < 75 x 10^9/L, Hb < 90g/L.
- Patients with renal dysfunction: Cr > 1.5 x ULN.
- Patients with liver dysfunction: Tbil > 1.5 x ULN.
- Uncontrolled brain metastases.
- Unwillingness or inability to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Peng Yuan, MD, 86-10-8778-8114, yuanpeng01@hotmail.com
Peng Yuan, MD
About this study
Official title: An Open-label, Single-arm, Phase II Study to Assess the Efficacy and Safety of Endostar® (Recombinant Human Endostatin Injection) Plus Gemcitabine and Docetaxel in Treatment of Soft Tissue Sarcoma Patients With Pulmonary Metastases
The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases.
Read the detailed description
Anticipated 30 subjects will be enrolled to receive Endostar, Gemcitabine and Docetaxel. Endostar at a dosage of 7.5 mg/m2 will be administered on Day 1-14 of each cycle. Gemcitabine (1000 mg/m2) will be administered on Day 1 and Day 8 of each cycle. Docetaxel (75 mg/m2) will be administered on Day 2 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is PD or until a maximum of 6 cycles. Time-to-progression (TTP) will be assessed using the Kaplan Meier method. Overall response rate (ORR) as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST (v1.1). Evaluation of 1- and 2-year overall survival will also be performed. Safety measures will be recorded using the NCI-CTCAE (v4.0).
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Endostar, Gemcitabine, Docetaxel
- Keywords
- Soft Tissue Sarcoma, Pulmonary metastases
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
Also called Recombinant Human Endostatin Injection
Endostar administered at 7.5 mg/m2, intravenously (IV), on Day 1-14 every 21 days for up to 4-6 consecutive cycles
GemcitabineDrug
Gemcitabine administered at 1000 mg/m2, intravenously (IV), on Day 1 and Day 8, every 21 days for up to 4-6 consecutive cycles
DocetaxelDrug
Docetaxel administered at 75 mg/m2, intravenously (IV), on Day 2, every 21 days for up to 4-6 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| Endostar | Experimental | Endostar, Gemcitabine, Docetaxel Receives: Drug: Endostar; Drug: Gemcitabine; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Progression
Time to progression is defined as time from first study treatment dose to the progression disease.
Measured: Approximately 2 years
Secondary outcomes (3)
Overall Response Rate
Measured: Approximately 2 years
Evaluate 1-year and 2-year overall survival rates
Measured: Approximately 2 years
Safety measures
Adverse events, Clinical and laboratory data including physical examinations, vital signs, ECG results, Use of concomitant medications
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peng Yuan
- Responsible party
- Sponsor-investigator, Peng Yuan, Chinese Academy of Medical Sciences
- Investigators
- Peng Yuan, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812018
- Sponsor's protocol ID
- CH-SAR-001
- Status last verified
- Mar 2013
- First submitted
- 13 Mar 2013
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Phase II Study to Assess the Efficacy and Safety of Endostar® (Recombinant Human Endostatin Injection) Plus Gemcitabine and Docetaxel in Treatment of Soft Tissue Sarcoma Patients With Pulmonary Metastases
- ClinicalTrials.gov ID
- NCT01812018
- Acronym / sponsor ID
- CH-SAR-001
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft Tissue Sarcoma, Pulmonary metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peng Yuan
- Study start
- Nov 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 15 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases.
Detailed description
Anticipated 30 subjects will be enrolled to receive Endostar, Gemcitabine and Docetaxel. Endostar at a dosage of 7.5 mg/m2 will be administered on Day 1-14 of each cycle. Gemcitabine (1000 mg/m2) will be administered on Day 1 and Day 8 of each cycle. Docetaxel (75 mg/m2) will be administered on Day 2 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is PD or until a maximum of 6 cycles. Time-to-progression (TTP) will be assessed using the Kaplan Meier method. Overall response rate (ORR) as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST (v1.1). Evaluation of 1- and 2-year overall survival will also be performed. Safety measures will be recorded using the NCI-CTCAE (v4.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endostar | Experimental | Drug: Endostar, Drug: Gemcitabine, Drug: DocetaxelEndostar, Gemcitabine, Docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18-70 years, male or female.
- ECOG performance status <=2.
- Life expectancy >= 3 months.
- Histologically or cytologically confirmed soft tissue sarcoma (GIST excluded).
- Patients must have had a prior anthracycline and/or ifosfamide in either the adjuvant or metastatic setting but not more than one regimen.
Key exclusion criteria (11 listed)
- Females who are pregnant or breastfeeding or have Childbearing potential unwilling to use effective contraception.
- Prior therapy with Gemcitabine, Docetaxel and Endostar.
- Subjects participating in other clinical trials within 4 weeks before enrollment.
- Accompanied by rapid progress of organ invasions, e.g.lesion areas are great than one half of liver or lung or have liver dysfunction.
- Uncontrolled central nervous system disorder or psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndostarAlso: Recombinant Human Endostatin InjectionEndostar administered at 7.5 mg/m2, intravenously (IV), on Day 1-14 every 21 days for up to 4-6 consecutive cycles | Drug | Endostar |
| GemcitabineGemcitabine administered at 1000 mg/m2, intravenously (IV), on Day 1 and Day 8, every 21 days for up to 4-6 consecutive cycles | Drug | Endostar |
| DocetaxelDocetaxel administered at 75 mg/m2, intravenously (IV), on Day 2, every 21 days for up to 4-6 consecutive cycles | Drug | Endostar |
Primary outcome
Time-to-Progression
Time frame: Approximately 2 years
Time to progression is defined as time from first study treatment dose to the progression disease.
3 secondary outcomes
Overall Response Rate
Time frame: Approximately 2 years
Evaluate 1-year and 2-year overall survival rates
Time frame: Approximately 2 years
Safety measures
Time frame: Approximately 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Yuan, MD principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endostar, Gemcitabine and Docetaxel in people with Soft Tissue Sarcoma, run by Peng Yuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Yuan, MD (86-10-8778-8114, yuanpeng01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Progression (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.