Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Antimetabolites

2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

Placebo

Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.

Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Multicenter Study of Immediate Postoperative Instillation of Gemcitabine in Patients With Superficial Transitional Cell Carcinoma of the Bladder

Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.

Time from enrollment to first confirmation of histopathological recurrence or disease progression. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.

Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.

Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition).

Eli Lilly and Company

Chief Medical Officer

Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)

Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)

Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

Total

Age Continuous

Sex: Female, Male

Germany

Turkey

Region of Enrollment

70 - Unable to carry on normal activity

80 - Activity with effort; some signs of disease

90 - Normal activity; minor signs of disease

100 - Normal no complaints; no evidence of disease

Unspecified

Classifies patients according to their functional impairment. Rating occurs in steps of 10 score points (0=death, 10, 20,....up to 100=Normal no complaints, no evidence of disease). Lower scores indicate poorer patient condition.

Karnofsky Performance Status

Recurrent Disease

Newly Diagnosed

Newly Diagnosed versus Recurrent Disease

White

Race/Ethnicity

No Lesions (No Specific Sites Documented)

1 Lesion

2 Lesions

3 Lesions

4 Lesions

>=5 Lesions

The initial TUR-BT was the first and mandatory TUR-BT during the study. An optional second TUR-BT was allowed.

Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions

pTx: Primary Tumor Cannot be Assessed

pT0: No Evidence of Primary Tumor

pTa: Noninvasive Papillary Carcinoma

pT1: Tumor Invades Subepithelial Connective Tissue

>=pT2: Tumor Invades Wider Area

Cis: Carcinoma in situ ("Flat Tumor")

No Malignancy

Worst staging of the initial and optional second transurethral resection of bladder tumor.

Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage

G1 - Well Differentiated

G2 - Moderately Differentiated

G3 - Poorly Differentiated

G4 - Undifferentiated

GX - Unknown

Worst grading of the initial and optional second transurethral resection of bladder tumor.

Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade

The study was stopped early for futility reasons. In addition, due to limitations in this databank, some original outcome measures are not disclosed. Time to Recurrence and Recurrence-Free Survival in Subgroups had data that were un-estimated.

Sample-size calculation based on estimated 1-year recurrence-free survival (RFS) rates of 63% (gemcitabine) and 50% (placebo). 191 critical events were required to detect a difference in RFS (80% power, log-rank test, alpha=0.050). Sample size of 328 patients with clinical evidence of superficial bladder cancer needed to observe these 191 events within a 24-month follow-up period, assuming 246 of these patients would receive instillation and have histopathological diagnosis of pTa/pT1(G1-3/Gx).

This is the Full Analysis Set population and contains all randomized participants who received the single instillation of Gemcitabine or Placebo.

Recurrence-Free Survival (RFS)

Recurrence-Free at 12 Months

Recurrence-Free at 24 Months

Because median time to recurrence was not reached, percentage of participants without event was estimated using Kaplan-Meier method. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.

Efficacy Eligible population contains the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.

Percentage of Participants Without Tumor Recurrence

Low Risk (G1/G2) - 12 Months (N=106, N=109)

Low Risk (G1/G2) - 24 Months (N=106, N=109)

High Risk (G3) - 12 Months (N=13, N=14)

High Risk (G3) - 24 Months (N=13, N=14)

Newly Diagnosed Disease - 12 Months (N=94, N=98)

Newly Diagnosed Disease - 24 Months (N=94, N=98)

Recurrent Disease - 12 Months (N=30, N=26)

Recurrent Disease - 24 Months (N=30, N=26)

With BCG - 12 Months (N=13, N=21)

With BCG - 24 Months (N=13, N=21)

Without BCG - 12 Months (N=111, N=103)

Without BCG - 24 Months (N=111, N=103)

RFS rate was estimated using Kaplan-Meier method. RFS was analyzed in different subgroups based on risk, disease status, and concomitant Bacillus Calmette-Guerin (BCG) instillations. Risk: Grading (G1,G2,G3) was performed according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer. Newly diagnosed disease: Initial diagnosis at study entry. Recurrent disease: history of at least one superficial bladder tumor that was surgically treated and relapsed prior to study entry. With BCG: received at least one instillation of BCG during study. Without BCG: didn't receive BCG.

Efficacy Eligible population consists of the Full Analysis Set (randomized) participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.

Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months

Because median time to recurrence was not reached in placebo arm, percentages of participants without recurrence are reported as post-hoc outcome measure (see #5. Post-hoc Outcome Measure). Efficacy Eligible population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.

Time to Recurrence

Because median time for RFS was not reached in all subgroups, patients (%) with RFS are reported as post-hoc outcome #6. There was no statistically significant difference between treatment arms in any subgroup. Population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.

Recurrence-Free Survival (RFS) in Subgroups

No Tumor Recurrence

Superficial Tumor - Stage pTa or pT1

Muscle-Invasive Tumor - Any Stage ≥pT2

pTx - Tumor Cannot be Assessed

Efficacy Eligible population consists of the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.

Spots Global Cancer Trial Database for Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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