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Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on April 10, 2001.   Last Updated on November 2, 2010   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer - EORTC
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00014274
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium.

PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
 Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: methotrexate
Drug: vinblastine sulfate
 Phase II
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: Methotrexate Carboplatin Gemcitabine Gemcitabine hydrochloride Vinblastine sulfate Vinblastine
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Duration of survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC v2 [ Designated as safety issue: Yes ]

Estimated Enrollment: 225
Study Start Date: January 2001
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate, carboplatin, and vinblastine in patients with transitional cell cancer of the urothelium who are ineligible for cisplatin-based chemotherapy.
  • Compare the toxicity and acute and intermediate (1-2 years) side effects of these regimens in these patients.
  • Compare the complete response rates, progression-free survival, and overall survival of patients treated with these regimens.
  • Compare the symptoms and quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive methotrexate* IV and vinblastine IV on days 1, 15, and 22 and carboplatin IV over 1 hour on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: * Methotrexate is omitted for patients with pleural effusion or ascites until complete resolution and for patients with a glomerular filtration rate less than 30 mL/min or creatinine greater than 2 mg/dL

Patients in either arm who achieve a complete response (CR) receive 2 additional courses of chemotherapy beyond CR.

Quality of life is assessed at baseline, after every 2 courses of chemotherapy, and within 6 weeks of completion of therapy.

Patients are followed within 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 156 patients (78 per treatment arm) will be accrued for the phase II portion of this study. A total of 225 patients will be accrued for the phase II + III portions of this study within 5 years.

  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 cancer of the urothelium, including the renal pelvis, ureters, urinary bladder, and urethra, meeting 1 of the following criteria:

    • Unresected positive lymph node
    • Distant metastases (M1, stage IV)
    • Unresectable primary bladder cancer (T3-4)
  • Measurable disease

  • Ineligible for cisplatin-based chemotherapy and presenting with the following:

    • WHO performance status 2 AND/OR
    • Glomerular filtration rate greater than 30 mL/min but less than 60 mL/min
  • No brain metastases or other CNS lesions

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 125,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.25 times normal
  • AST/ALT no greater than 3 times normal (5 times normal if liver metastases are present)

Renal:

  • See Disease Characteristics
  • Calcium normal

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • No psychological, familial, sociological, or geographical condition that would preclude study participation
  • No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior systemic biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • No prior systemic cytotoxic therapy (including adjuvant and neoadjuvant chemotherapy)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 months since prior radiotherapy
  • Prior radiotherapy to study lesions allowed if there is evidence of disease progression

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014274

  Show 29 Study Locations
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Gerwin Kaiser, MD Klinikum Nuernberg - Klinikum Nord
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Skoneczna I, Marreaud S, de Wit R, Sylvester R. Randomized Phase II/III Trial Assessing Gemcitabine/Carboplatin and Methotrexate/Carboplatin/Vinblastine in Patients With Advanced Urothelial Cancer "Unfit" for Cisplatin-Based Chemotherapy: Phase II--Results of EORTC Study 30986. J Clin Oncol. 2009 Sep 28; [Epub ahead of print]
De Santis M, Bellmunt J, Mead B, et al.: Randomized phase II/III study assessing gemcitabine/carboplatin (GC) and methotrexate/carboplatin/vinblastine (M-CAVI) in previously untreated patients (pts) with advanced urothelial cancer ineligible for cisplatin based chemotherapy: phase II results of. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-288, 2008.

ClinicalTrials.gov Identifier: NCT00014274     History of Changes
Other Study ID Numbers: CDR0000068525, EORTC-GU-30986
Study First Received: April 10, 2001
Last Updated: November 2, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
anterior urethral cancer
 posterior urethral cancer
urethral cancer associated with invasive bladder cancer
metastatic transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urethral Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Kidney Diseases
Ureteral Diseases
Methotrexate
Gemcitabine
Vinblastine
Carboplatin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012



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