Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer

NCT00005086 | Completed Phase 2

• 3 other identifiers: 11203UCCRC-11203NCI-G00-1733
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

stage IV bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

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

  2 years

Study Arms (1)

Arm A

EXPERIMENTAL

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

Interventions

cisplatin DRUG

Arm A

docetaxel DRUG

Arm A

gemcitabine hydrochloride DRUG

Arm A

methotrexate DRUG

Arm A

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Docetaxel; Gemcitabine; Methotrexate

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Walter M. Stadler, MD, FACP

  University of Chicago

  STUDY CHAIR

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: April 6, 2000
• First Posted: May 16, 2003
• Study Start: August 1, 1999
• Primary Completion: August 1, 2002
• Study Completion: April 1, 2005
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (4)