Mesothelioma
Conditions
Keywords
Mesothelioma, inoperable, relapsed
Brief summary
A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.
Interventions
DRUGVinorelbine
DRUGVandetanib
once daily oral dose
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with mesothelioma * Previously treated with only one course of chemotherapy for mesothelioma * No previous treatment with vinorelbine * No serious heart problems within the last 3 months
Exclusion criteria
* Serious abnormal laboratory values * Severe or uncontrolled disease or condition as judged by the Investigator * Pregnant or breast-feeding women * Other cancers within the last 5 years * Major surgery or radiation therapy within 4 weeks prior to starting study therapy * Receipt of any investigational agents within 30 days prior to commencing study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disease Control. | Assessed at 2 months. | Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Objective Response. | Assessed at 2 months. | Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. |
| Progression-free Survival (PFS) | Assessed from baseline to 12 months. | Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. |
| Overall Survival (OS) | Assessed from baseline to 12 months. | — |
Countries
Germany, Switzerland
Participant flow
Recruitment details
First subject enrolled: 17 December 2007, Last subject last visit: 22 July 2009. The study was conducted at 2 centres in Switzerland and 4 centres in Germany.
Participants by arm
| Arm | Count |
|---|---|
| Vandetanib Vandetanib 300 mg/day oral | 13 |
| Vinorelbine Vinorelbine 30 mg/m2 iv, administrated weekly | 10 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Progressive disease | 11 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Vandetanib | Vinorelbine | Total |
|---|---|---|---|
| Age, Continuous | 67 Years | 64 Years | 65.5 Years |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 13 | 10 / 10 |
| serious Total, serious adverse events | 6 / 13 | 3 / 10 |
Outcome results
Primary
Number of Participants With Disease Control.
Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.
Time frame: Assessed at 2 months.
Population: Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vandetanib | Number of Participants With Disease Control. | 0 Participants |
| Vinorelbine | Number of Participants With Disease Control. | 5 Participants |
Secondary
Number of Participants With Objective Response.
Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.
Time frame: Assessed at 2 months.
Population: Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vandetanib | Number of Participants With Objective Response. | 0 Participants |
| Vinorelbine | Number of Participants With Objective Response. | 0 Participants |
Secondary
Overall Survival (OS)
Time frame: Assessed from baseline to 12 months.
Population: Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vandetanib | Overall Survival (OS) | 7.8 Months |
| Vinorelbine | Overall Survival (OS) | 6.4 Months |
Secondary
Progression-free Survival (PFS)
Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.
Time frame: Assessed from baseline to 12 months.
Population: Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vandetanib | Progression-free Survival (PFS) | 1.8 Months |
| Vinorelbine | Progression-free Survival (PFS) | 3.8 Months |