Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.

Study Overview

• Status: Terminated
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: irinotecan hydrochloride; Drug: gemcitabine hydrochloride

Detailed Description

OBJECTIVES:

Primary

• Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan.

Secondary

• Determine the duration of response in patients treated with this regimen.
• Determine the tolerance to and toxicity of this regimen in these patients.
• Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond best response.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Hollings Cancer Center at Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma of the bladder

  • Locally advanced or metastatic disease

• Unidimensionally measurable disease by physical exam or imaging study

  • The following are not considered measurable disease:

    • Bone only disease
    • Pleural or peritoneal effusions
    • CNS lesions
    • Irradiated lesions unless disease progression was documented after radiotherapy
• Not amenable to surgery

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2.0 mg/dL

Renal

• Creatinine ≤ 2.0 mg/dL

Gastrointestinal

• No active inflammatory bowel disease
• No significant bowel obstruction
• No chronic diarrhea

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other active malignancy except nonmelanoma skin cancer
• No mental incapacitation or psychiatric illness that would preclude giving informed consent
• No other severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

• No more than 1 prior platinum-based chemotherapy regimen
• At least 4 weeks since prior chemotherapy
• No prior irinotecan or gemcitabine
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), and intermittent dexamethasone as an antiemetic

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• No concurrent palliative radiotherapy

Surgery

• Not specified

Other

• No concurrent participation in another clinical trial

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: Gemcitabine and Irnotecan	Drug: irinotecan hydrochloride; Drug: gemcitabine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response Proportion	From registration until time of complete response or partial response

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Response	From registration until disease progression among patients who had at least a partial response.
Frequency of Adverse Events as Assessed by NCI CTC Version 2.0	From the day of first dose until the end of study, an average of 6 months
Progression-free Survival	Time between registration and disease progression or death, whichever comes first.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: August 4, 2004
• First Submitted That Met QC Criteria: August 4, 2004
• First Posted (Estimate): August 5, 2004

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: stage III bladder cancer; recurrent bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Gemcitabine; Irinotecan
• Other Study ID Numbers: CDR0000378047; MUSC-100615; PHARMACIA-440EONCO020298; MUSC-HR-10212