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Randomized Phase II Trial Of Adjuvant Chemotherapy For Urothelial Carcinoma Comparing GC To Dose-Dense MVAC


Phase 2
18 Years
N/A
Not Enrolling
Both
Anterior Urethral Cancer, Localized Transitional Cell Cancer of the Renal Pelvis and Ureter, Posterior Urethral Cancer, Recurrent Bladder Cancer, Recurrent Urethral Cancer, Regional Transitional Cell Cancer of the Renal Pelvis and Ureter, Stage III Bladder Cancer, Transitional Cell Carcinoma of the Bladder, Ureter Cancer, Urethral Cancer Associated With Invasive Bladder Cancer

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Trial Information

Randomized Phase II Trial Of Adjuvant Chemotherapy For Urothelial Carcinoma Comparing GC To Dose-Dense MVAC


PRIMARY OBJECTIVES

To estimate the difference in the rate of unacceptable toxicity for dose-dense methotrexate,
vinblastine, doxorubicin, and cisplatin (MVAC) and gemcitabine and cisplatin (GC) in the
adjuvant treatment of urothelial cancer.

SECONDARY OBJECTIVES

To compare rates of disease recurrence at 3 years between dose-dense MVAC and GC.

To determine whether molecular markers excision repair cross-complementing-1 (ERCC-1)
ribonucleoside-diphosphate reductase M-1 (RRM-1), breast cancer 1 (BRCA1) topoisomerase
2-alpha (Top2A) and protein 53 (p53) can predict those patients more likely to benefit from
chemotherapy.

To investigate the potential utility of cytidine deaminase (CDA), ERCC-1, xeroderma
pigmentosum group D (XPD), glutathione S-transferase P-1 (GSTP-1) and glutathione
S-transferase M-1 (GSTM-1) as molecular markers which predict occurrence of significant
toxicity during adjuvant chemotherapy for urothelial cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive cisplatin intravenously (IV) on day 1 and gemcitabine hydrochloride
IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence
of disease progression or unacceptable toxicity.

ARM B: Patients receive methotrexate IV on day 1, vinblastine IV, doxorubicin hydrochloride
IV, cisplatin IV on day 2 and pegfilgrastim subcutaneously (SC) on day 3. Treatment repeats
every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years.


Inclusion Criteria:



- Histologically confirmed high-grade urothelial carcinoma, stage T3bN0, T4N0 or any T
stage with lymph node involvement, completely resected; including upper tract
urothelial carcinoma

- The dominant histology must be transitional cell or urothelial but foci of other
histologies less than 20 percent of the total tumor volume are permitted

- Absence of metastatic disease on radiographic imaging

- Patients must be enrolled and able to start treatment within 90 days of radical
cystectomy or radical nephrectomy

- Creatinine less than institutional upper limit of normal (ULN) or clearance greater
or equal to 50 mL/min (may be calculated by Cockcroft-Gault formula or measured from
24-hour urine collection)

- Serum total bilirubin less or equal to 1.5 x ULN (except for patients with Gilbert's)

- Alkaline phosphatase less or equal to 2.5 x ULN

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate
transaminase (SGPT) less or equal to 2.5 x ULN

- White blood cells (WBC) greater or equal to 3000

- Absolute neutrophil count (ANC) greater or equal to 1500

- Hemoglobin (Hb) greater or equal to 9

- Platelets greater or equal to 100,000

- Normal left ventricular ejection fraction, by echocardiogram or multi gated
acquisition scan (MUGA)

- Patients must be recovered from surgery

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Willing and able to provide informed consent

- Willingness to use barrier contraception during study period

Exclusion Criteria:

- The presence of significant pleural effusion or ascites

- Prior systemic chemotherapy for urothelial carcinoma including neoadjuvant
chemotherapy (prior intravesical therapy is permitted)

- History of malignancy within preceding 5 years, aside from non-melanoma skin cancer
or previously treated or incidentally detected prostate cancer with undetectable PSA
(after radical cystectomy or prostate cancer therapy)

- Peripheral neuropathy greater than grade 1

- The presence of active heart disease such as congestive heart failure or unstable
angina

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of unacceptable toxicity graded according to Common Terminology Criteria (CTC) v4.0

Outcome Description:

80% confidence intervals (CI) will be constructed; for unacceptable toxicity, the confidence interval will be one-sided.

Outcome Time Frame:

Assessed up to 3 years

Safety Issue:

Yes

Principal Investigator

Tanya Dorff

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

4B-10-5

NCT ID:

NCT01639521

Start Date:

May 2013

Completion Date:

May 2013

Related Keywords:

  • Anterior Urethral Cancer
  • Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Posterior Urethral Cancer
  • Recurrent Bladder Cancer
  • Recurrent Urethral Cancer
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage III Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Ureter Cancer
  • Urethral Cancer Associated With Invasive Bladder Cancer
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Ureteral Neoplasms
  • Urethral Neoplasms
  • Kidney Neoplasms

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