Salvage Docetaxel for Pretreated Urothelial Cancer

A Phase II Study of Salvage Docetaxel in Patients With Advanced Urothelial Cancer Failed to Prior Chemotherapy

Based on the previous clinical experience in other cancers, and considering the absence of current standard salvage regimens, the single agent docetaxel is selected as the regimen for this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe myelosuppression observed in other cancer trials warrants further study in urothelial cancer. The objective of the study is to evaluate the safety and activity of weekly docetaxel given as salvage therapy for advanced urothelial cancer.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: Docetaxel

Detailed Description

Study scheme

Patients eligible for this study will be offered participation. Screening numbers are endowed to all subjects who sign the informed consent forms. These screening numbers are used as 'Subject Identification Code" along with subject initials. Subjects withdrawn from the study retain their screening number.

Patients will have study drug discontinued at the time of progression and will then remain on study for a 4-week safety follow-up. Those without progression may continue to receive docetaxel as long as this is considered to be in their interest by their physician. After progression, patients will remain on study for the purpose of collecting follow-up and survival information.

VII-3. Study treatment

The study drug doses should be calculated taking the body surface area into consideration. Docetaxel 30 mg/m2 will be administered on days 1 and 8 every 3 weeks. Docetaxel will be diluted in 250 ml 0.9% saline or 5% dextrose to produce a final solution with concentration of 0.3-0.74 mg/ml. It will be administered as an infusion over 60 min on each infusion day. Patients will be premedicated with iv dexamethasone 15 mg, antihistamines and a prophylactic antiemetic treatment prior to docetaxel infusion in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Patients experiencing adverse events attributed to irinotecan should have treatment delay as needed and/or may be interrupted or reduced depending on individual tolerability and according to the protocol.

Treatment will be continued until disease progression, unacceptable toxicities, or consent withdrawal. After failure of study treatment, further treatment can be administered at the discretion of investigators.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 135710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged over 20 years or older
• histologically confirmed metastatic and/or unresectable urothelial carcinoma arising from bladder, ureter, or renal pelvis
• ECOG performance status of 0 or 1
• measurable disease, or evaluable lesion(s), as defined by RECIST
• clinical failure of the prior chemotherapy for advanced disease, including gemcitabine and platinum
• adequate major organ functions
• written informed consent

Exclusion Criteria:

• severe co-morbid illness and/or active infections
• prior treatment with taxanes (paclitaxel and docetaxel)
• any patients judged by the investigator to be unfit to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: docetaxel; Days 1 & 8 Docetaxel 35 mg/m2 IV	Drug: Docetaxel; Treatment will be continued until progression, unacceptable toxicity, or refusal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response rate	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	6 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	every 3 weeks

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Soon Il Lee, MD, Dankook University Hospital, Cheonan, Korea

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Estimate): May 15, 2014
• Last Update Submitted That Met QC Criteria: May 14, 2014
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: 2010-03-072