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A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer


OBJECTIVES:

- Determine the response rate to the combination of docetaxel and methotrexate followed
by gemcitabine and cisplatin in patients with stage IV locally advanced or metastatic,
previously untreated, transitional cell carcinoma of the urothelium.

- Assess the toxicities of this sequential regimen in this patient population.

- Assess time to event efficacy measures including time to disease progression, duration
of response, and overall survival in these patients treated with this sequential
regimen.

OUTLINE: Patients receive methotrexate IV on days 1 and 8 and docetaxel IV over 1 hour on
day 8 every 3 weeks for 9 weeks. Patients then receive cisplatin IV over 2 hours on day 1
and gemcitabine IV over 100 minutes on days 1 and 8 every 3 weeks for 9 weeks. This 18 week
sequential regimen constitutes 1 full course. Treatment continues in the absence of
unacceptable toxicity or disease progression.

Patients are followed until death or until 2 years after study entry, whichever comes first.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV locally advanced or metastatic transitional cell
carcinoma of the urothelium that is not amenable to curative surgery or radiotherapy

- T4b or N2 or N3 or M1

- No pure adenocarcinomas, pure squamous carcinomas, or small cell carcinoma

- Evaluable or bidimensionally measurable disease If only single lesion, must not be
within portal of prior irradiation

- No active CNS metastases

- Adequately treated CNS metastases eligible provided stable for 8 weeks following
therapy and no longer requires steroids or antiseizure medication

- No clinically significant pleural effusions or ascites unless drained prior to
administration of methotrexate

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- CALGB 0-1

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

- Bilirubin less than 1.5 mg/dL

- SGOT less than 2.5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min

Cardiovascular:

- No uncontrolled cardiac disease (e.g., congestive heart failure, arrhythmia, or
angina)

Pulmonary:

- No uncontrolled pulmonary disease (e.g., chronic obstructive pulmonary disease)

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- No concurrent active infection

- No known hypersensitivity to docetaxel, methotrexate, cisplatin, gemcitabine,
filgrastim (G-CSF), oprevelkin, or any component of these products

- No serious concurrent medical disorder

- No medical or psychiatric conditions that would compromise consent or preclude
completion of study

- No other malignancy within the past 3 years except:

- Carcinoma in situ of the cervix

- Adequately treated nonmelanoma skin cancer

- Stage I or II prostate cancer provided adequate local therapy (surgery or radiation)
has been administered and PSA is less than 1.0 ng/mL

- No preexisting peripheral neuropathy grade 2 or greater

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy for metastatic disease

- At least 6 months since prior neoadjuvant or adjuvant chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent steroids

Radiotherapy:

- See Disease Characteristics

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 3 weeks since prior major surgery and recovered

Other:

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

11203

NCT ID:

NCT00005086

Start Date:

August 1999

Completion Date:

April 2005

Related Keywords:

  • Bladder Cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana  46885-5099