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

NCT00089128 | Terminated Phase 2 Results DMC

• 4 other identifiers: CDR0000378047MUSC-100615PHARMACIA-440EONCO020298MUSC-HR-10212
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

transitional cell carcinoma of the bladder; recurrent bladder cancer; stage III bladder cancer; stage IV bladder cancer

Outcome Measures

Primary Outcomes (1)

• Response Proportion

  From registration until time of complete response or partial response

Secondary Outcomes (3)

• 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.

Study Arms (1)

Gemcitabine and Irnotecan

EXPERIMENTAL

Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride

Interventions

gemcitabine hydrochloride DRUG

Gemcitabine and Irnotecan

irinotecan hydrochloride DRUG

Gemcitabine and Irnotecan

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gemcitabine; Irinotecan

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Results Point of Contact

• Title: Kate Anderton
• Organization: Medical University of South Carolina

anderton@musc.edu

843-792-2708

Study Officials

• Uzair B. Chaudhary, MD

  Medical University of South Carolina

  STUDY CHAIR

• Gustavo Leone

  Medical University of South Carolina, Hollings Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: November 1, 2001
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 12, 2018
• Results First Posted: July 12, 2018

Record last verified: 2018-06

Locations

US (1)