Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer - CILAB

• Conditions: ocally Advanced/Metastatic Urothelial Tract or Bladder Cancer; MedDRA version: 9.1Level: LLTClassification code 10005003Term: Bladder cancer

• Registration Number: EUCTR2007-001943-23-SE
• Lead Sponsor: Sanofi-Aventis Recherche et Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-11
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

- Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic (lymph node or visceral) urothelial tract or bladder cancer.

- ECOG Performans Status 0 or 1.

- No prior palliative chemotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age < 18 years old.
- Disease localized only to the radiation fields without radiologically confirmed progression of the disease within the radiation fields after completion of prior radiotherapy.

PRIOR THERAPY:
- (Neo) Adjuvant chemotherapy if < 6 months of (Neo)adjuvant chemotherapy and relapse
- Less than 6 weeks elapsed from prior radiotherapy (in case of palliative radiotherapy for pain or bleeding control 6-week interval is not mandatory providing the patient recovered from all toxicities) and less than 3 weeks from surgery to time of randomization. Patients pN+ with no residual disease after surgery are not eligible
- Treatment with an investigational agent within 4 weeks (6 weeks for immunotherapy) of study enrollment

BIOLOGICAL CRITERIA:
- Bone marrow function as defined by absolute neutrophil count < 1.5 x 10e9/L, platelet < 75 x10e9/L, or hemoglobin < 9.0 g/dL.
- Alkaline phosphatase (AP) = 2.5 x UNL associated with AST/ALT > 2.5 x UNL, or AP > 2.5 x UNL and = 5.0 x UNL associated with AST/ALT > 1.5 UNL or AP > 5.0 x UNL
- Total Bilirubin > 1.0 x UNL
- Creatinine > 1.0 x ULN, except in case of creatinine > 1.0 x ULN and = x ULN if actual creatinine clearance = 60 ml/min

PAST or CURRENT HISTORY
- History or new evidence of brain metastases or leptomeningeal disease
- History of another neoplasm. Patients with prior history of either non metastatic non melanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery, small filed radiation or chemotherapy =5 years prior to randomization will be eligible.
- Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose> 300 mg/m²
- Peripheral neuropathy > grade 1
- History of inflammatory bowel disease, significant bowel obstruction.
- History of hypersensitivity to platinum, gemcitabine, taxanes, polysorbate 80, or to compounds with similar chemical structures.
- Known human immunodefieciency virus (HIV) infection immunodeficency-syndrome (AIDS)-related illness.
- Any other active illness such as active uncontrolled infections, uncontrolled cardiac disease or hypertension, uncontrolled diabetes that would preclude safe administration of study therapy at the time of randomization.

CONCOMITANT TREATMENT
- Concurrent treatment with strong inhibitors of CYP P450 3A4 or patients planning to receive there treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization

- Concurrent treatment with strong inhibitors of cytochrome P450 2C8 (gemfibrozile) or patients planning to receive this treatment. For patients who were receiving treatment with such agent, a one-week washout period is required prior to randomization.

Others
Refer to the Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified