ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.

Overview

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.

Full Title of Study: “ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder. A Phase II Marker Lesion. STUDY”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 29, 2015

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

  • Drug: Oncofid-P-B
    • Paclitaxel – Hyaluronic Acid 600 mg – Solution for intravesical administration.

Arms, Groups and Cohorts

  • Experimental: Oncofid-P-B
    • Oncofid-P-B will be administered once a week for 6 weeks in the first treatment phase and once a month for 6 months followed by other 6 months in the second maintenance phase

Clinical Trial Outcome Measures

Primary Measures

  • CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor.
    • Time Frame: 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 Measures

  • Time to relapse after Oncofid-P-B instillation during the maintenance phase.
    • Time Frame: 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.
    • Time Frame: 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″
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fidia Farmaceutici s.p.a.
  • Provider of Information About this Clinical Study
    • Sponsor

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