Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer
A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer
NCT00005086CI-TRIAL-00012008completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- 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.
- interventionNames
- Drug: cisplatin
- Drug: docetaxel
- Drug: gemcitabine hydrochloride
- Drug: methotrexate
Primary outcomes (1)
- measure
- Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.