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Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00146276
Recruitment Status : Unknown
Verified September 2005 by Association of Urologic Oncology (AUO).
Recruitment status was:  Recruiting
First Posted : September 7, 2005
Last Update Posted : September 27, 2006
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Association of Urologic Oncology (AUO)

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date September 27, 2006
Study Start Date  ICMJE July 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
progression-free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00146276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • overall survival
  • toxicity and tolerability of gemcitabine
  • quality of life (EORTC QLQ-C30, version 2.0)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer
Official Title  ICMJE Adjuvant vs. Progression-Triggered Treatment With Gemcitabine After Radical Cystectomy for Locally Advanced Transitional Cell Carcinoma of the Bladder in Patients Not Suitable for Cisplatin-Based Chemotherapy - A Phase 3 Study
Brief Summary

Primary Objective:

  • To analyse time to tumor progression in patients cystectomized for locally advanced transitional cell carcinoma (TCC) of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age). Patients are randomized to receive either adjuvant gemcitabine immediately after radical operation (treatment arm A) or no treatment (control arm B). Patients in the control arm are to be treated with gemcitabine as soon as tumor progression becomes evident clinically and/or radiologically.

Secondary Objectives:

The secondary objectives of this study are:

  • Estimation of time-specific survival probabilities irrespective of causes of death.
  • Assessment of toxicity and tolerability of gemcitabine
  • Description of survival experience of patients in the control arm beyond the time of initiating chemotherapy.
  • Assessment of quality of life (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30).

Study Design:

This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study using gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced TCC of the bladder in an adjuvant setting. The patients will receive the following treatment:

Arm A (treatment): gemcitabine 1250 mg/m2 intravenously once a week for 2 weeks (days 1 and 8) followed by 1-week rest period. Repeat cycle on day 22. Maximum of 6 cycles. Begin treatment until 3 months after radical operation (within first 6 weeks is recommended).

Arm B (control): No immediate post-surgery treatment. Watchful waiting; treatment only conditionally in case of progression with gemcitabine (dose and schedule as in arm A).

Detailed Description

Primary Objective:

  • To analyse time to tumor progression in patients cystectomized for locally advanced TCC of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age). Patients are randomized to receive either adjuvant Gemcitabine immediately after radical operation (treatment arm A) or no treatment (control arm B). Patients in the control arm are to be treated with Gemcitabine as soon as tumor progression becomes evident clinically and/or radiologically.

Secondary Objectives:

The secondary objectives of this study are:

  • Estimation of time-specific survival probabilities irrespective of causes of death.
  • Assessment of toxicity and tolerability of Gemcitabine
  • Description of survival experience of patients in the control arm beyond the time of initiating chemotherapy.
  • Assessment of quality of life (EORTC QLQ-C30).

Study Design:

This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study using Gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced TCC of the bladder in an adjuvant setting. The patients will receive the following treatment:

Arm A (treatment): Gemcitabine 1250 mg/m2 intravenously once a week for 2 weeks (days 1 and 8) followed by 1-week rest period. Repeat cycle on day 22. Maximum of 6 cycles. Begin treatment until 3 months after radical operation (within first 6 weeks is recommended).

Arm B (control): No immediate post-surgery treatment. Watchful waiting; treatment only conditionally in case of progression with Gemcitabine (dose and schedule as in arm A).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Carcinoma, Transitional Cell
Intervention  ICMJE Drug: gemcitabine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 2, 2005)
178
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Status after radical cystectomy for transitional cell carcinoma of the bladder, stages pT3a, pT3b, pT4a and/or pN1, pN2 (but no more than 5 lymph nodes positive for tumor) [International Union Against Cancer (UICC) criteria, 1997]. Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components. Complete tumor removal by radical operation has to be established macroscopically and microscopically (R0 resection).
  • Patients regarded as inappropriate for cisplatin-based chemotherapy (i.e. impaired renal function with at least 30 ml/min calculated creatinine clearance and serum-creatinine less than 3.0 mg/dl, age > 70) are eligible for study enrollment [calculation of creatinine clearance according to Cockcroft and Gault formula]. Decision left to the investigator's discretion.
  • Patient has no prior history of systemic chemotherapy regimens. Previous local intravesical adjuvant chemotherapy or immunotherapy is allowed.
  • Prior radiation therapy is allowed if it has been completed at least 12 weeks before enrollment into the study and the patient has recovered from all toxic effects.
  • Performance status of 60 or higher on the Karnofsky Scale.
  • Patient compliance, mental state, and geographic proximity allow adequate followup
  • Adequate bone marrow reserve: white blood cell (WBC) count >= 3.5 x 10^9/L, platelets >= 100 x 10^9/L, and hemoglobin >= 10 g/dL (or >= 6.2 mmol/L or >= 100 g/L).
  • Adequate liver function with bilirubin < 1.25 times above upper limit of normal range; alanine transaminase (ALT) or aspartate transaminase (AST) < 2.5 times normal upper limit.
  • Males or females at least 18 years of age who are considered fit for gemcitabine chemotherapy.
  • Signed informed consent by the patient.

Exclusion Criteria:

  • Tumor was not completely removed (visible tumor or enlarged lymph nodes left or positive margins microscopically-R1 or R2 resection)
  • Patient has a distant metastasis or metastases.
  • Tumor stage pT4b or more than 5 locoregional lymph nodes are positive for tumor.
  • Adeno- and/or squamous cell carcinoma of the bladder without transitional cell carcinoma component (different responses to chemotherapy).
  • Time interval between radical cystectomy and the first day of chemotherapy exceeds 3 months for patients enrolled in the treatment arm.
  • Serum creatinine >= 3.0 mg/dl (>= 265 mmol/l)
  • Active infection (at the discretion of the investigator) .
  • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
  • Patients with a history of prior malignancy other than basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or incidental carcinoma of the prostate must be clinically free of disease for at least 5 years prior to study entry.
  • Use of any investigational agent in the month before enrollment into the study.
  • White blood cell (WBC) count < 3.5 x 10^9/L or platelets < 100 x 10^9/L or hemoglobin < 10 g/dL (or < 6.2 mmol/L or < 100 g/L).
  • Bilirubin >= 1.25 times above upper limit of normal range; alanine transaminase (ALT) or aspartate transaminase (AST) >= 2.5 times upper limit of normal range
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00146276
Other Study ID Numbers  ICMJE B9E-MC-S062
AB 22/00
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Association of Urologic Oncology (AUO)
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Michael Stöckle, MD Dept of Urology, Saarland University
PRS Account Association of Urologic Oncology (AUO)
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP