Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IV locally advanced or metastatic bladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: methotrexate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer |
- Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 6 |
| Study Start Date: | August 1999 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
Methotrexate will be given as a short infusion (introduced into a vein) for approximately 5 minutes on the first day (day 1). ). A week later (day 8), both methotrexate and docetaxel will be given the same way, but this will take about 1 hour. The first course of treatment consists of receiving treatment on day 1 and day 8 every 21 days for 9 weeks. X-rays or scans will then be performed to determine if your tumor is shrinking. You will then start treatment with gemcitabine and cisplatin. On the first day (day 1), you will receive both cisplatin and gemcitabine into your vein. A week later (day 8), you will receive only gemcitabine as an infusion into your vein over 100 minutes and no additional intravenous fluid will be required on that day. This second course of treatment consists of receiving treatment on day 1 and day 8 every 21 days for 9 weeks.
|
Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: methotrexate |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Inc. | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
More Information
Additional Information:
No publications provided
| Responsible Party: | Walter Stadler, Professor, Dir Genitourinary Oncology, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00005086 History of Changes |
| Other Study ID Numbers: | 11203, UCCRC-11203, NCI-G00-1733 |
| Study First Received: | April 6, 2000 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Chicago:
|
stage IV bladder cancer transitional cell carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Docetaxel Cisplatin Methotrexate Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Antiviral Agents |
ClinicalTrials.gov processed this record on May 19, 2013