Non-Invasive Papillary Carcinoma of Bladder
Conditions
Keywords
paclitaxel, bladder cancer, hyaluronic acid
Brief summary
The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.
Detailed description
This study will investigate the preliminary activity of Oncofid-P-B administered by intravescical route at the Recommended Dose of 600 mg, once a week, for six weeks evaluating the ablative activity on a papillary marker tumor in patients suffering from non-muscle invasive cancer of the bladder. When a patient will present a Complete Response at the end of the six weekly administration of Oncofid-P-B , he/she can enter a second phase of the study defined maintenance phase. During this phase, the patients will be treated with the study drug administered by intravesical infusion once a month for 2 cycles of treatment with the duration of 6 months separated by a period during which study drug will not be administered, due to the necessity to perform histological evaluation of efficacy. This scheme will follow a clinical usual approach for the maintenance treatment of patients suffering from non-muscle invasive cancer of the bladder. Complete Response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other site and negative cytology.
Interventions
DRUGOncofid-P-B
Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.
Sponsors
Fidia Farmaceutici s.p.a.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes aged \> 18 years, women in menopause (defined as surgically sterile or one year postmenopausal); * Cytological or histological diagnosis of bladder cancer; * Multiple primary or recurrent Ta G1-G2 papillary cancer; * ECOG Performance Status 0 to 1; * Adequate bone marrow function: neutrophils ≥1.5 103/mL; platelet count ≥100 103/ mm3; Hb ≥ 10 g/dL; * Written informed consent; * Willing and able to comply with the protocol for the duration of the study.
Exclusion criteria
* Hypersensitivity to Paclitaxel or one of its constituents; * T1 papillary cancer or muscle-invasive disease (T2-T4) ; * Previous or concomitant tumor of the upper urinary tract, of the prostatic urethra, CIS; * Any other malignancy diagnosed within 3 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix); * Presence of significant urologic disease interfering with intravesical therapy; * Participation in another clinical trial with any investigational drug within 30 days prior to study screening or concurrent treatment with other experimental drugs; * Other chemotherapy or radiotherapy within four weeks of study entry; * Previous intravesical immunotherapy or chemotherapy less than 3 months before study entry; * Bladder capacity less than 300 mL; * Renal and hepatic function values exceeding 2 times the upper normal value; * Severe cardiovascular diseases considered a contraindication to intravesical treatment; * Pregnant, lactating or childbearing potential aged women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor. | Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7) | Rate of complete response, estimated at V8, after 6 weeks of weekly study drug administration: number and percentage of patients with complete response. Complete response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other sites and negative cytology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to relapse after Oncofid-P-B instillation during the maintenance phase. | The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks). | Time to relapse after Oncofid-P-B instillation during the maintenance phase. |
| Number of patients with relapse within V 22. | The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks). | Number of patients with relapse within V 22. |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks). | Treatment-Related Adverse Events as Assessed by CTCAE v4.0 with Oncofid-P-B given by intravesical instillation. |
Countries
Germany, Italy, Spain
Outcome results
None listed