Lobaplatin and Gemcitabine in Combination, Second-line Treatments on Advanced OsteosarcomaPhase 2/3NCT02099396
A Clinical Trial on Efficacy and Safety for Lobaplatin and Gemcitabine in Combination With Docetaxel in the Second-line Treatments on Advanced Osteosarcoma
A Phase 2/3 study testing Docetaxel+lobaplatin and Gemcitabine+lobaplatin in people with Lobaplatin and Gemcitabine in Combination, Second-line Treatments on Advanced Osteosarcoma, run by China Association of Osteosarcoma Chemotherapy.
Trial summary
The purpose was to evaluate efficacy, safety and effects on survival for lobaplatin and Gemcitabine in combination with Docetaxel, which can provide a kind of completely new second-line chemotherapy program for osteosarcoma patients in aggressive-phase, provide accurate and reliable evidence-based results for clinical… Read more about this study
- Who is it for?
- Ages 8 to 40 years
- Conditions the study is for
- Lobaplatin and Gemcitabine in Combination, Second-line Treatments on Advanced Osteosarcoma
- What is being tested?
- Docetaxel+lobaplatin and Gemcitabine+lobaplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jun 2016
- Phase
- Phase 2/3
- 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 8 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. 8-40 years old, male or female
- 2. Osteosarcoma in aggressive-phase confirmed by histopathology. Local tumors and isolated pulmonary foci must be confirmed by pathological diagnosis, and pathological examinations are not required for pulmonary multiple metastatic tumors
- (Definition for osteosarcoma in aggressive-phase:
- Primary tumors or locally recurrent tumors that are impossible to cure or it can be radically cured by amputation but patients refuse
- osteosarcoma showing distal metastasis, metastatic tumors that are unable for radical cure by operations or other local therapeutic methods (such as stereotaxic radiosurgery, argon-helium knife, ultrasonic focusing knife)
- patients refuse or could not tolerate operations or other local treatments for both primary tumors and metastatic tumors.)
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- But the patients as below are not included:
- Pulmonary metastasis complicated with more than three osseous metastasis foci at the same time
- Local recurrent foci of bigger than 200mm3
- More than three pulmonary metastasis foci of bigger than 3cm
- Diffusive pulmonary metastasis
- More than 10 metastatic foci of bigger than 1 cm in both lungs
- Intracranial metastasis
- Multiple metastasis in pelvis
- Formation of tumor embolus in great vessels (thigh vessels, iliac vessels, peritoneal cavity vessels, vessels in armpits, infraclavicular vessels)
- Coelom effusion 3. Patients fails in the treatments with the first-line chemotherapeutics for osteosarcoma (HD-MTX, ADM, DDP, IFO), those having ever used at least three kinds of first-line drugs.
- 4. Patients showing progression of disease within six months after neoadjuvant chemotherapy or adjunctive chemotherapy for osteosarcoma as well as first-line chemotherapy, permission from the subjects or their legal representatives should be obtained for patients showing progression of disease for more than six months.
- 5. Measurable foci are detected at baseline according to RECIST 1.1 edition. 6. ECOG physical efficiency score at 0-1, anticipated life span for more than three months.
- 7. Recovery from previous treatments: according to NCI-CTC AE 4.0 edition, all of the adverse reactions (except baldness) recover to grade one or even lower.
- 8. Peripheral hemogram and blood biochemical indicators as follows indicate proper organ functions: Hemoglobin (Hb)≥ 90g/L, Neutrophilic granulocyte (ANC)≥1.5×109/L, Blood platelet count (Plt)≥ 80×109/L, Serum creatinine (Cr)≤ 1.5×upper normal limit (ULN), blood urea nitrogen (BUN)≤ 2.5×upper normal limit (ULN); Total bilirubin (TB)≤ ULN; Alkaline phosphatase (ALP)≤ 2.5×ULN; Aspartate aminotransferase (AST) and glutamate pyruvate transaminase (ALT)≤ 2.5×ULN; albumen (ALB)≥ 25 g/L。 9. Pregnancy test (urinary β-HCG) negative (suitable for women in reproductive life having sexual activities).
- 10. Informed consent (or signed by their legal representatives) are signed to testify that they understand the purpose of the study and the operations required in the study, and they are willing to participate in the present study, and the subjects below 18 year old should sign the informed consent for minors.
Who cannot join
- 1. Previous exposure to lobaplatin / docetaxel, lobaplatin / gemcitabine, docetaxel / gemcitabine.
- 2. Within three weeks after the last systemic cytotoxic drug medication, radiotherapy or treatments with any test drug.
- 3. Suffering from other malignant tumors during the past three years. Exceptions: skin basal cell carcinoma or nonmetastatic squamous cell carcinoma, carcinoma in situ of uterine cervix, or FIGO period 1 cervical cancer.
- 4. Previously known metastasis to central nervous system. 5. Myocardial infarction within six months before inclusion, grade II or higher cardiac failure defined in New York Cardiac Association, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, pericardial diseases with clinical significance, or electrocardiogram indicates acute ischemia or abnormalities in reactive conducting system.
- 6. Uncontrolled complications, including but not confined to: poorly controlled hypertension or diabetes, persistent reactive infections, or psychological diseases or social situations that may affect the compliance of the subjects to the research.
- 7. Previously known allergic reactions, hypersensitivity or intolerance to lobaplatin, docetaxel, gemcitabine or adjuvant.
- 8. Women in pregnancy or lactation. 9. Any situation pointed by the researcher that may impair the subjects or lead to incapability to meet with or implement the requirements of the research.
About this study
The purpose was to evaluate efficacy, safety and effects on survival for lobaplatin and Gemcitabine in combination with Docetaxel, which can provide a kind of completely new second-line chemotherapy program for osteosarcoma patients in aggressive-phase, provide accurate and reliable evidence-based results for clinical applications of lobaplatin in osteosarcoma patients as one of the third-generation of platinum drugs, and further consummate and enrich clinical practice guidance on osteosarcoma all over the world.
- Conditions
- Lobaplatin and Gemcitabine in Combination, Second-line Treatments on Advanced Osteosarcoma
- Being tested
- Docetaxel+lobaplatin, Gemcitabine+lobaplatin
- Keywords
- PFS,efficacy and safety,lobaplatin and gemcitabine in combination, second-line treatments on advanced osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel+lobaplatinDrug
Gemcitabine+lobaplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| docetaxel+lobaplatin | Experimental | Pretreatment: 15 mg dexamethasone is administered orally every day since one day before administration with docetaxel for continuous three days. Dexamethasone 10 mg i.v. and promethazine 25mg im are administered 30 min before administration with docetaxel to prevent anaphylactic responses.
Intravenous infusion with docetaxel 75mg/m2 for one hour is carried out on the first day of each cycle for 21 days; intravenous infusion with lobaplatin 30 mg/m2 for two hours is carried out on the second day; q3wkb Receives: Drug: Docetaxel+lobaplatin |
| gemcitabine+lobaplatin | Experimental | Pretreatment: 15 mg dexamethasone is administered orally every day since one day before administration with docetaxel for continuous three days. Dexamethasone 10 mg i.v. and promethazine 25mg im are administered 30 min before administration with docetaxel to prevent anaphylactic responses.
Intravenous infusion with gemcitabine 675mg/m2 for 90 min is carried out on the first day and the eighth day of each cycle for 21 days; intravenous infusion with lobaplatin 30 mg/m2 for two hours is carried out; intravenous infusion with docetaxel 75mg/m2 for one hour is carried out on the first day; q3wkb Receives: Drug: Gemcitabine+lobaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
Major parameter: progression free survival (PFS) Progression free survival (PFS): it refers to the period from the day of randomization in the groups to any progression of disease or death with records.
Measured: 2 years
Secondary outcomes (2)
Minor parameters: objective remission rate (ORR)
Overall survival (OS): it refers to the period from the date of randomization in the groups to death induced by any reason with records. The ending date of last correspondence should be recorded for all of the subjects lost from follow-ups before termination of the clinical trials or quit from the tests. The last date for survival will be recorded as the ending for the subjects still accepting treatments.
Measured: 2 years
Minor parameters: overall survival (OS), safety.
Objective remission rate (ORR): it refers to the percentage of patients for whom tumors decrease to certain sizes and maintain for a period, including CR and PR cases. The criteria for evaluations on therapeutic efficacy are divided into complete remission (CR), partial remission (PR), stable disease (SD) and progression of disease (PD) according to the RECIST criteria (please refer to attachment 1 for details).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lobaplatin and Gemcitabine in Combination, Second-line Treatments on Advanced OsteosarcomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Association of Osteosarcoma Chemotherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099396
- Sponsor's protocol ID
- ChinaAOC-2014-001
- Status last verified
- Mar 2014
- First submitted
- 26 Mar 2014
- Last updated
- 28 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial on Efficacy and Safety for Lobaplatin and Gemcitabine in Combination With Docetaxel in the Second-line Treatments on Advanced Osteosarcoma
- ClinicalTrials.gov ID
- NCT02099396
- Acronym / sponsor ID
- ChinaAOC-2014-001
- Conditions
- Lobaplatin and Gemcitabine in Combination, Second-line Treatments on Advanced Osteosarcoma
- Keywords
- PFS,efficacy and safety,lobaplatin and gemcitabine in combination, second-line treatments on advanced osteosarcoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China Association of Osteosarcoma ChemotherapyUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 28 Mar 2014 (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 was to evaluate efficacy, safety and effects on survival for lobaplatin and Gemcitabine in combination with Docetaxel, which can provide a kind of completely new second-line chemotherapy program for osteosarcoma patients in aggressive-phase, provide accurate and reliable evidence-based results for clinical applications of lobaplatin in osteosarcoma patients as one of the third-generation of platinum drugs, and further consummate and enrich clinical practice guidance on osteosarcoma all over the world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| docetaxel+lobaplatin | Experimental | Drug: Docetaxel+lobaplatinPretreatment: 15 mg dexamethasone is administered orally every day since one day before administration with docetaxel for continuous three days. Dexamethasone 10 mg i.v. and promethazine 25mg im are administered 30 min before administration with docetaxel to prevent anaphylactic responses. Intravenous infusion with docetaxel 75mg/m2 for one hour is carried out on the first day of each cycle for 21 days; intravenous infusion with lobaplatin 30 mg/m2 for two hours is carried out on the second day; q3wkb |
| gemcitabine+lobaplatin | Experimental | Drug: Gemcitabine+lobaplatinPretreatment: 15 mg dexamethasone is administered orally every day since one day before administration with docetaxel for continuous three days. Dexamethasone 10 mg i.v. and promethazine 25mg im are administered 30 min before administration with docetaxel to prevent anaphylactic responses. Intravenous infusion with gemcitabine 675mg/m2 for 90 min is carried out on the first day and the eighth day of each cycle for 21 days; intravenous infusion with lobaplatin 30 mg/m2 for two hours is carried out; intravenous infusion with docetaxel 75mg/m2 for one hour is carried out on the first day; q3wkb |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- 1. 8-40 years old, male or female
- 2. Osteosarcoma in aggressive-phase confirmed by histopathology. Local tumors and isolated pulmonary foci must be confirmed by pathological diagnosis, and pathological examinations are not required for pulmonary multiple metastatic tumors
- Primary tumors or locally recurrent tumors that are impossible to cure or it can be radically cured by amputation but patients refuse
- osteosarcoma showing distal metastasis, metastatic tumors that are unable for radical cure by operations or other local therapeutic methods (such as stereotaxic radiosurgery, argon-helium knife, ultrasonic focusing knife)
- patients refuse or could not tolerate operations or other local treatments for both primary tumors and metastatic tumors.)
Key exclusion criteria (7 listed)
- 2. Within three weeks after the last systemic cytotoxic drug medication, radiotherapy or treatments with any test drug.
- 3. Suffering from other malignant tumors during the past three years. Exceptions: skin basal cell carcinoma or nonmetastatic squamous cell carcinoma, carcinoma in situ of uterine cervix, or FIGO period 1 cervical cancer.
- 4. Previously known metastasis to central nervous system. 5. Myocardial infarction within six months before inclusion, grade II or higher cardiac failure defined in New York Cardiac Association, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, pericardial diseases with clinical significance, or electrocardiogram indicates acute ischemia or abnormalities in reactive conducting system.
- 6. Uncontrolled complications, including but not confined to: poorly controlled hypertension or diabetes, persistent reactive infections, or psychological diseases or social situations that may affect the compliance of the subjects to the research.
- 7. Previously known allergic reactions, hypersensitivity or intolerance to lobaplatin, docetaxel, gemcitabine or adjuvant.
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 |
|---|---|---|
| Docetaxel+lobaplatin | Drug | docetaxel+lobaplatin |
| Gemcitabine+lobaplatin | Drug | gemcitabine+lobaplatin |
Primary outcome
progression free survival (PFS)
Time frame: 2 years
Major parameter: progression free survival (PFS) Progression free survival (PFS): it refers to the period from the day of randomization in the groups to any progression of disease or death with records.
2 secondary outcomes
Minor parameters: objective remission rate (ORR)
Time frame: 2 years
Minor parameters: overall survival (OS), safety.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Docetaxel+lobaplatin and Gemcitabine+lobaplatin in people with Lobaplatin and Gemcitabine in Combination, Second-line Treatments on Advanced Osteosarcoma, run by China Association of Osteosarcoma Chemotherapy.
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 21 inclusion and 7 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 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: 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 28 Mar 2014.