A Phase 2 interventional study of Gemcitabine and Cisplatin (DD GC) in Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can help shrink the tumor better than standard chemotherapy given on a standard treatment schedule before the patient undergoes surgery for bladder cancer.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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This is a Multicenter Phase II study of dose-dense (DD) gemcitabine and cisplatin (GC) neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are candidates for radical cystectomy.
Drug: Gemcitabine and Cisplatin (DD GC)
Patients will receive six cycles of GC administered every 14 days. Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)
Pathologic Response Rate
Defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of lymph node metastases (N0) on the final cystectomy specimen. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.
Time frame: 1 year
Number of Participants With Toxicity
Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.
Time frame: 1 year
2 Year Recurrence Free Survival (RFS) Rate for Responders
Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.
Time frame: 2 years
2 Year Recurrence Free Survival (RFS) Rate for Nonresponders
Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.
Time frame: 2 years
| Milestone | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| Started | 51 |
| Completed | 49 |
| Not completed | 2 |
| Withdrew: Did not receive treatment | 2 |
Defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of lymph node metastases (N0) on the final cystectomy specimen. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.
| percentage of participants | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| Pathologic Response Rate | 57 (42 to 70) |
Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.
| Participants | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| Number of Participants With Toxicity | 51 |
Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.
| percentage of participants | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| 2 Year Recurrence Free Survival (RFS) Rate for Responders | 95 |
Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.
| percentage of participants | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| 2 Year Recurrence Free Survival (RFS) Rate for Nonresponders | 52 |
Collected over Within 30 days of study treatment, an average of 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gemcitabine and Cisplatin (DD GC) | 7/51 (13.7%) | 17/51 (33.3%) | 51/51 (100%) |
| Event | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| Urinary tract infectionInfections and infestations | 4/51 |
| DehydrationMetabolism and nutrition disorders | 3/51 |
| VomitingGastrointestinal disorders | 3/51 |
| Abdominal PainGastrointestinal disorders | 2/51 |
| Creatinine IncreasedInvestigations | 2/51 |
| Infections and infestations - OtherInfections and infestations | 2/51 |
| FeverGeneral disorders | 1/51 |
| Heart failureCardiac disorders | 1/51 |
| HematuriaRenal and urinary disorders | 1/51 |
| NauseaGastrointestinal disorders | 1/51 |
| Event | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| AnemiaBlood and lymphatic system disorders | 44/51 |
| FatigueGeneral disorders | 41/51 |
| Platelet count decreasedInvestigations | 33/51 |
| Alkaline phosphatase increasedInvestigations | 32/51 |
| NauseaGastrointestinal disorders | 32/51 |
| HyperglycemiaMetabolism and nutrition disorders | 27/51 |
| ConstipationGastrointestinal disorders | 22/51 |
| HypomagnesemiaMetabolism and nutrition disorders | 21/51 |
| AlopeciaSkin and subcutaneous tissue disorders | 20/51 |
| HypocalcemiaMetabolism and nutrition disorders | 17/51 |
| Age, Continuous(years) | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| Median | 64 (37 to 77) |
| Sex: Female, Male(Participants) | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| Female | 9 |
| Male | 42 |
| Ethnicity (NIH/OMB)(Participants) | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 50 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 46 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Gemcitabine and Cisplatin (DD GC) |
|---|---|
| United States | 51 |
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Memorial Sloan Kettering Cancer Center