A Phase 2 interventional study of Gemcitabine hydrochloride and Paclitaxel in Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter and Proximal Urethral Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Gemcitabine hydrochloride · Drug: Paclitaxel · Drug: Doxorubicin hydrochloride · Drug: Pegfilgrastim
Gemcitabine 900 mg/m\^2 IV over 90 minutes repeat every 14 days.
Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
135 mg/m\^2 IV over 1 hour
Also known as: Anzatax, Asotax, TAX, Taxol
Doxorubicin 40 mg/m\^2 IV over 20 minutes
Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Subcutaneously injection on day 1.
Also known as: Filgrastim SD-01, GCSF-SD01, Neulasta, SD-01 sustained duration G-CSF
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.
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.
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.
Time frame: 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.
Time frame: Up to 3 years
Recruitment period: April 24, 2007 to November 10, 2011. All recruitment done within Community Clinical Oncology Programs (CCOP) medical clinics, specifically The University of Texas MD Anderson Cancer Center and the Ozarks Regional CCOP.
| Milestone | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| Started | 39 |
| Completed | 39 |
| Not completed | 0 |
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.
| percentage of participants | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| Objective Response Rate | 56.4 (39.6 to 72.2) |
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.
| Hazard Ratio | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| Complete Response | 0.25 (0.07 to 0.95) |
| Partial Response | 1.09 (0.44 to 2.70) |
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.
| participants | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| Neutropenic Fever | 4 |
| Treatment Delay | 0 |
Collected over Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gemcitabine, Paclitaxel and Doxorubicin | — | 39/39 (100%) | 34/39 (87.2%) |
| Event | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| GranulocytopeniaBlood and lymphatic system disorders | 13/39 |
| LeukopeniaInvestigations | 8/39 |
| AnemiaBlood and lymphatic system disorders | 6/39 |
| ThrombocytopeniaInvestigations | 6/39 |
| Neutropenic FeverBlood and lymphatic system disorders | 4/39 |
| FatigueGeneral disorders | 4/39 |
| HyperuricemiaMetabolism and nutrition disorders | 4/39 |
| MucositisGastrointestinal disorders | 4/39 |
| HyperglycemiaMetabolism and nutrition disorders | 4/39 |
| LymphopeniaInvestigations | 3/39 |
| Event | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| AnemiaBlood and lymphatic system disorders | 32/39 |
| Creatinine IncreasedInvestigations | 26/39 |
| FatigueGeneral disorders | 17/39 |
| HyperglycemiaMetabolism and nutrition disorders | 14/39 |
| Platelet Count DecreasedInvestigations | 13/39 |
| Peripheral Sensory NeuropathyNervous system disorders | 13/39 |
| AnorexiaMetabolism and nutrition disorders | 11/39 |
| PainMusculoskeletal and connective tissue disorders | 11/39 |
| HyperuricemiaMetabolism and nutrition disorders | 10/39 |
| Edema LimbsGeneral disorders | 10/39 |
| Age, Continuous(years) | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| Median | 72 (51 to 89) |
| Sex: Female, Male(Participants) | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| Female | 11 |
| Male | 28 |
| Region of Enrollment(participants) | Gemcitabine, Paclitaxel and Doxorubicin |
|---|---|
| United States | 39 |
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center