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

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00089128
First received: August 4, 2004
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Designated as safety issue: No ]
  • Tolerance [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Median and progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: November 2001
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089128

Locations
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Study Chair: Uzair B. Chaudhary, MD Medical University of South Carolina
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00089128     History of Changes
Other Study ID Numbers: CDR0000378047, MUSC-100615, PHARMACIA-440EONCO020298, MUSC-HR-10212
Study First Received: August 4, 2004
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
transitional cell carcinoma of the bladder
recurrent bladder cancer
stage III bladder cancer
stage IV bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Irinotecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014