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
4 other identifiers
interventional
40
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2007
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 23, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
October 9, 2020
CompletedOctober 9, 2020
September 1, 2020
8.2 years
May 23, 2007
June 29, 2016
September 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
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.
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.
Secondary Outcomes (2)
Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
Registration Date of each participant for up to three years or death whichever came first
Safety and Efficacy of Same-day Pegfilgrastim
Up to 3 years
Study Arms (1)
Gemcitabine, Paclitaxel and Doxorubicin
EXPERIMENTALPaclitaxel 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.
Interventions
Gemcitabine 900 mg/m\^2 IV over 90 minutes repeat every 14 days.
135 mg/m\^2 IV over 1 hour
Doxorubicin 40 mg/m\^2 IV over 20 minutes
Subcutaneously injection on day 1.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, 65802, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nizar M Tannir, MDChair Ad Interim, Genitourinary Medical Oncology
- Organization
- UT MD Anderson Cancer Center, Community Clinical Oncology Program Research Base
Study Officials
- PRINCIPAL INVESTIGATOR
Lance Pagliaro, MD, BA
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
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
May 23, 2007
First Posted
May 24, 2007
Study Start
April 1, 2007
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 9, 2020
Results First Posted
October 9, 2020
Record last verified: 2020-09