Clinical trial · Interventional
Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function
A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency
- 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)
This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Distal Urethral Cancer | Distal Urethral Carcinoma | ALIAS | 0.90 |
| Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Proximal Urethral Cancer | Proximal Urethral Carcinoma | ALIAS | 0.90 |
| Recurrent Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Recurrent Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
| Regional Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| Gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine, Paclitaxel and Doxorubicin
- description
- Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 min; Doxorubicin 40 mg/m\^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1.
- interventionNames
- Drug: Gemcitabine hydrochloride
- Drug: Paclitaxel
- Drug: Doxorubicin hydrochloride
- Drug: Pegfilgrastim
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate.
- description
- The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder, urethra, or upper urinary tract * Mixed TCC and variant histologies (i.e., small cell, squamous cell, adenocarcinoma, or sarcoma) allowed if present in \< 50% of the biopsy specimen * Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution. * Measurable disease: may include radiographic detection of metastases in lymph nodes (\>= 1.5 cm) or liver or lung (\>= 1.0 cm) OR pelvic mass palpable on examination under anesthesia * Creatinine clearance \< 60 mL/min; no renal insufficiency that requires hemodialysis; no renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy) * Zubrod performance status 0-2 * Platelet count \> 100,000/mm\^3 * Absolute granulocyte count \> 1,500/mm\^3 * Bilirubin =\< 2.0 mg/dL * Aminotransferases (AST and ALT) =\< 2 times upper limit of normal * Left ventricular ejection fraction (LVEF) \> 40% OR normal electrocardiogram (EKG or ECG) and no history of cardiac disease * All patients must be evaluated in the Department of Genitourinary Medical Oncology at M. D. Anderson Cancer Center or participating CCOP center prior to signing informed consent. * No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy * Prior intravesicular chemotherapy allowed Exclusion Criteria: * No brain metastases * Not pregnant or nursing * No severe or uncontrolled infection * No New York Heart Association class III-IV congestive heart failure, unstable angina, or history of myocardial infarction within the past 6 months * No peripheral neuropathy \>= grade 2 * No persistently uncontrolled diabetes mellitus * No chronic liver disease * No HIV positivity * No other malignancy except nonmelanoma skin cancer unless disease-free for the past 3 years * No overt psychosis, mental disability, or other condition that would preclude giving informed consent * No known sickle cell disease * No uncontrolled severe hypertension * Renal insufficiency that requires hemodialysis or renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy).
References
Publications (0)
Data not yet available