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Randomized Phase II Study of Vinflunine as Maintenance Monotherapy in Patients With Advanced or Metastatic Urothelial Cancer That Obtains Clinical Benefit of the First Line With Cisplatin-gemcitabine Combination

Phase 2
18 Years
80 Years
Not Enrolling
Carcinoma, Transitional Cell

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Trial Information

Randomized Phase II Study of Vinflunine as Maintenance Monotherapy in Patients With Advanced or Metastatic Urothelial Cancer That Obtains Clinical Benefit of the First Line With Cisplatin-gemcitabine Combination

Vinflunine is a drug recently approved in Europe for the treatment of advanced or metastatic
urothelial cancer after platinum-failure. It has proved to improve the survival results
compared with the best suportive care. In adition, the tolerability was favourable,
specially for not leading appearance of neuropathy nor other cumulative toxic effects.

In this study, it is proposed to test the feasibility, in terms of tolerability and efficacy
of monotherapy with vinflunine in patients who, after completing the first-line
cisplatin-based treatment for Transitional Cell Carcinoma of the Urothelial Tract (CCTU),
have reached a stabilization or objective response. In order to have an adequate control
group in the proposed design will be a phase II trial in which one group will receive
standard management (follow-up until progression disease).

Inclusion Criteria:

- Age > 18 & < 80

- Written informed consent given by the patient

- Diagnosis of urothelium cells transition cancer subsidiary locally advanced or
metastatic resection

- One measurable target lesion minimum

- ECOG 0 or 1

- Stabilization or objective response after first-line treatment 6 cycles of

- Last administration of cisplatin and gemcitabine < 6 weeks

- Maximum grade I toxicity

- Adequate functions of bone marrow, kidney and liver

- Absence psychological, family, sociological or geographical disorder or other

- Women of childbearing potential must be using a medically accepted method of
contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy
during the 2 months preceding the start of study treatment, throughout the study
period and for up to 3 months after the last dose of study treatment in such a manner
that the risk of pregnancy is minimised. Women of childbearing potential must have a
negative serum or urine pregnancy test within 72 hours prior to the start of study

- Fertile men must be using an effective method of birth control if their partners are
women of childbearing potential up to 3 months after last administration of study

Exclusion Criteria:

- ECOG > 2

- Patients with age > 80

- Patients with small cell carcinoma histology, lymphomas or sarcomas of the bladder.

- The patients that have received 7 or more cycles of a combination of cisplatin and
gemcitabine in first line metastatic disease.

- Pregnant or lactating women or women with positive pregnancy test at screening,
fertile sexual active women that did not use or do not wish or are unable to use an
accepted method to prevent pregnancy during the 2 months prior to study treatment,
during the study period and up to 3 months after the last dose of study treatment.
Sexual active men who do not wish to use a method of birth during the study and up to
6 months after the last dose of study treatment if their partners are women of
childbearing age.

- Known brain metastases or meningeal involvement. CT Scan not required to rule this
unless there is clinical suspicion of disease of the central nervous system.

- Peripheral neuropathy grade 2 according to NCI-CTC version 4.0 [Common Toxicity
Criteria of the National Cancer Institute].

- Prior radiation to > 30% of the bone marrow, radiation completed at least 30 days or
current persistence of any adverse event.

- Other serious diseases or medical conditions like: systemic infection that required a
systemic anti-infective treatment(grades 3 or 4 of the Common Toxicity Criteria NCI,
version 4.03) and uncontrolled medical disorder, for example: patients with unstable
angina or myocardial infarction within 6 months before registration or uncontrolled

- Progressive Disease during 1st line treatment of advanced or metastatic disease with
chemotherapy systemic cisplatin and gemcitabine.

- Patients who have received more than one line of treatment for metastatic disease.

- Patients who received cisplatin in monotherapy or in combination as neoadjuvant
treatment, adjuvant after initial surgery of urothelial cancer.

- Patients treated with another investigational drug or treatment antineoplastic agent
cisplatin or gemcitabine than within 30 days before randomization.

- Other cancers except basal skin cancer treated in an appropriate, cervical cancer in
situ or other tumor a disease-free interval of 5 years.

- Inadequate renal function defined by a calculated clearance serum creatinine < 40
ml/min (Cockcroft-Gault).

- Known hypersensitivity to drug study or similar chemical structure drugs.

- Patients who require treatment with ketoconazole, itraconazole, ritonavir,
amprenavir, indinavir, rifampin or phenytoin (any potent inhibitor or inducer of

- Any concurrent chronic immunotherapy or prior organic allograft.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival.

Outcome Description:

To evaluate the Progression Free Survival (PFS) with vinflunine in maintenance monotherapy in patients with advanced or metastatic CCTU that has reached stabilization or objective response after completing 6 cycles with the combination cisplatin-gemcitabine in 1st line.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Jesús García-Donas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario Fundación Alcorcón.


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

February 2012

Completion Date:

February 2014

Related Keywords:

  • Carcinoma, Transitional Cell
  • urothelium
  • transitional
  • carcinoma
  • cancer
  • metastatic
  • tract
  • Carcinoma
  • Carcinoma, Transitional Cell