Distal Urethral CancerPhase 2NCT00478361
Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function
A Phase 2 study testing Gemcitabine hydrochloride, Paclitaxel and Doxorubicin hydrochloride in people with Distal Urethral Cancer and Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer
- What is being tested?
- Gemcitabine hydrochloride, Paclitaxel and Doxorubicin hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, 65802
About this study
Official title: A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the efficacy of gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride, and pegfilgrastim, in terms of response rate, in patients with metastatic or unresectable transitional cell carcinoma of the bladder or urinary tract and renal insufficiency.
SECONDARY OBJECTIVES:
- Assess the safety and tolerability of this regimen in these patients. II. Determine the median time to progression in patients treated with this regimen.
III. Determine the median survival duration in patients treated with this regimen.
IV. Assess the safety and efficacy of pegfilgrastim in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride intravenous (IV) over 20 minutes, paclitaxel IV over 60 minutes, gemcitabine hydrochloride IV over 90 minutes, and pegfilgrastim subcutaneously on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
- Conditions
- Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer, Recurrent Bladder Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Gemcitabine 900 mg/m^2 IV over 90 minutes repeat every 14 days.
PaclitaxelDrug
Also called Anzatax, Asotax, TAX, Taxol
135 mg/m^2 IV over 1 hour
Also called ADM, ADR, Adria, Adriamycin PFS
Doxorubicin 40 mg/m^2 IV over 20 minutes
PegfilgrastimDrug
Also called Filgrastim SD-01, GCSF-SD01, Neulasta, SD-01 sustained duration G-CSF
Subcutaneously injection on day 1.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Paclitaxel and Doxorubicin | Experimental | 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. Receives: Drug: Gemcitabine hydrochloride; Drug: Paclitaxel; Drug: Doxorubicin hydrochloride; Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The overall survival was determined by grouping participants based upon their response based on RECIST. The groups are Complete Response(CR): All the cancerous lesion disappear, Partial Response (PR): All the measured lesions decrease by at least 30 percent, and Stable Disease(SD): No significant change in the disease burden. OS of complete response or partial response participants were compared to the reference group of stable disease participants in a Hazard Ratio(HR). If HR is greater than 1, the experimental group has a better outcome than the reference group. If HR is less than 1, the reference group has the better outcome.
Measured: Registration Date of each participant for up to three years or death whichever came first
Safety and Efficacy of Same-day Pegfilgrastim
Determined the number of participants who had either a fever due to abnormally low level of neutrophils, a type of white blood cell, on the day of study drug treatment, or the participants who had the study drug treatment delayed due to an abnormally low level of neutrophils.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distal Urethral CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lance Pagliaro, MD, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478361
- Sponsor's protocol ID
- 2005-0839
- Other IDs
- NCI-2009-00154, CDR0000544831, 2U10CA045809-17
- Status last verified
- Sep 2020
- First submitted
- 23 May 2007
- Last updated
- 9 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency
- ClinicalTrials.gov ID
- NCT00478361
- Acronym / sponsor ID
- 2005-0839
- Conditions
- Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer, Recurrent Bladder Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Assess the efficacy of gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride, and pegfilgrastim, in terms of response rate, in patients with metastatic or unresectable transitional cell carcinoma of the bladder or urinary tract and renal insufficiency.
SECONDARY OBJECTIVES:
- Assess the safety and tolerability of this regimen in these patients. II. Determine the median time to progression in patients treated with this regimen.
III. Determine the median survival duration in patients treated with this regimen.
IV. Assess the safety and efficacy of pegfilgrastim in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride intravenous (IV) over 20 minutes, paclitaxel IV over 60 minutes, gemcitabine hydrochloride IV over 90 minutes, and pegfilgrastim subcutaneously on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Paclitaxel and Doxorubicin | Experimental | Drug: Gemcitabine hydrochloride, Drug: Paclitaxel, Drug: Doxorubicin hydrochloride, Drug: PegfilgrastimPaclitaxel 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine hydrochlorideAlso: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, GemzarGemcitabine 900 mg/m^2 IV over 90 minutes repeat every 14 days. | Drug | Gemcitabine, Paclitaxel and Doxorubicin |
| PaclitaxelAlso: Anzatax, Asotax, TAX, Taxol135 mg/m^2 IV over 1 hour | Drug | Gemcitabine, Paclitaxel and Doxorubicin |
| Doxorubicin hydrochlorideAlso: ADM, ADR, Adria, Adriamycin PFSDoxorubicin 40 mg/m^2 IV over 20 minutes | Drug | Gemcitabine, Paclitaxel and Doxorubicin |
| PegfilgrastimAlso: Filgrastim SD-01, GCSF-SD01, Neulasta, SD-01 sustained duration G-CSFSubcutaneously injection on day 1. | Drug | Gemcitabine, Paclitaxel and Doxorubicin |
Primary outcome
Objective Response Rate
Time frame: 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.
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.
2 secondary outcomes
Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
Time frame: Registration Date of each participant for up to three years or death whichever came first
Safety and Efficacy of Same-day Pegfilgrastim
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Active, not recruitingPhase 2
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Bladder Cancer, Urethral Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lance Pagliaro, MD, BA principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine hydrochloride, Paclitaxel and Doxorubicin hydrochloride in people with Distal Urethral Cancer and Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.