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Dose Dense MVAC for Muscle Invasive Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01031420
Recruitment Status : Completed
First Posted : December 14, 2009
Results First Posted : August 21, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief Summary:
Standard treatment for early stage bladder cancer is chemotherapy with methotrexate (M), vinblastine (V), adriamycin (A), and cisplatin (C) followed by surgical removal of any remaining cancer and the bladder with the intent of cure. The M V chemotherapy is usually given every 14 days with the AC given along each 28 days. This study looks at giving the same drugs at the same doses closer together, all drugs every 14 days, with the support of growth factor medication to promote growth of the white blood cells and platelets and allow chemotherapy to be finished sooner and surgery to be done sooner.

Condition or disease Intervention/treatment Phase
Muscle Invasive Bladder Cancer High Risk Urothelial Carcinoma of the Upper Urinary Tracts Drug: single arm dose dense MVAC Phase 2

Detailed Description:

Primary Objective To assess the rate of complete response (pT0) at cystectomy or ureterectomy following preoperative dose dense MVAC (DD-MVAC) in patients with muscle invasive urothelial carcinoma of the bladder or high grade upper tract urothelial carcinoma.

Secondary Objectives To assess the toxicity profile of DD-MVAC when given in the neoadjuvant setting: To define the number of patients who complete all three cycles of treatment without dose reduction, and to compare incidence of toxicity to the historical standard described by Grossman et al. To assess the 5 year overall and relapse free survival in patients who receive neoadjuvant DD-MVAC. To compare complete response rates between the following subgroups of study patients: Among bladder patients: Clinical N0 versus N1 (Appendix B) Among bladder patients: T2 stage without high risk features versus T2 with high risk features plus those with > T2 stage.

Three 14 day cycles of:

Methotrexate 30 mg/m2 IV push or infusion over 2-3 minutes. Day 1

Vinblastine 3 mg/m2 Slow IV push or infusion over Day 1

Doxorubicin 30 mg/m2 Slow IV push or infusion over 15 minutes Day 1

Cisplatin 70 mg/m2 IV infusion over 4 hours Note: May divide dose over two sequential days (35 mg/m2/d x 2 days) if creatinine clearance 50-59 mL/min Day 1* (or divided over Day 1 and Day 2)

Pegfilgrastim 6 mg subcutaneous (SQ) 24-48 hours after completion of chemotherapy.

Followed in 4-8 weeks by radical cystectomy/ureterectomy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Dose Dense MVAC in Muscle Invasive Bladder Cancer and High Risk Urothelial Carcinoma of the Upper Urinary Tract
Actual Study Start Date : December 7, 2009
Actual Primary Completion Date : July 19, 2013
Actual Study Completion Date : August 7, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: dose dense MVAC
standard doses of MVAC given every 14 days x 3.
Drug: single arm dose dense MVAC
standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
Other Names:
  • methotrexate (MTX) sodium
  • MTX
  • Mexate
  • Mexate-AQ
  • Foex
  • Folex
  • Abitrexate
  • Rheumatrex
  • amethopterin
  • Velban
  • Velsar
  • AlkabanAQ
  • Velbe
  • vinblastine sulfate
  • vincaleukoblastine
  • VLB
  • doxorubicin
  • doxorubicin hydrochloride liposomal Doxil,
  • Rubex
  • Adria
  • cis-platinum, cisdiammineddichloroplatinum,
  • CDDP
  • Platinol
  • platinum




Primary Outcome Measures :
  1. Percentage of Participants With Complete Response at Cystectomy or Ureterectomy Following Preoperative Dose Dense MVAC [ Time Frame: Following completion of the 3rd/final cycle of chemotherapy (about week 9) by CT imaging and at time of surgery for pathologic response. ]
    complete response rate (pT0), as defined by pathologic staging at cystectomy or ureterectomy, following neoadjuvant DD-MVAC chemotherapy.


Secondary Outcome Measures :
  1. Toxicity Profile of Dose Dense MVAC Given in the Neoadjuvant Setting. [ Time Frame: Ongoing throughout treatment at each MD visit every 14 days. ]
    Defined by number of patients who complete all three cycles of treatment without dose reduction



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed urothelial carcinoma of bladder, ureter, or renal pelvis. T2-T4 and muscle invasion must be established by TURBT. Upper tract must be high grade. N0-N1 are eligible.
  • candidate for radical cystectomy, nephroureterectomy, or segmental ureterectomy with goal of cure.

    ->/= 18 years old

  • ECOG performance status 0-1.
  • Adequate marrow and organ function.
  • May enter on therapeutic anticoagulation if it can be safely held during perioperative period.
  • No women of childbearing potential, pregnant or breastfeeding.
  • LVEF >/= 50 %
  • Patients with history of other non-urothelial malignancies may enroll if: 1)no evidence of distant disease w/in last year. 2)No anticancer treatment for >/= 1 year other than adjuvant treatment or treatment for secondary prevention. 3) Less than 360 mg/m2 lifetime dose of adriamycin.
  • ability to understand and willingness to sign written informed consent and HIPAA.

Exclusion Criteria:

  • Intravesicular therapy w/in 4 weeks of study entry or those who have not recovered from adverse effects of such agents administered more than 4 weeks earlier.
  • Patients may not be receiving any investigational agents within 4 weeks of study entry.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Methotrexate, Vinblastine, Adriamycin or Cisplatin or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects of cytotoxic chemotherapy.
  • Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cytotoxic chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

    -. Patients who have undergone prior pelvic radiation are excluded due to risk of life threatening myelosuppression.

  • Patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031420


Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
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Principal Investigator: Elizabeth Plimack, MD Fox Chase Cancer Center
Additional Information:
Publications of Results:
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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01031420    
Other Study ID Numbers: FER-GU-026
NCI-2010-01910 ( Registry Identifier: NCI Clinical Trials Reporting Office )
First Posted: December 14, 2009    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: September 17, 2019
Last Verified: August 2019
Keywords provided by Fox Chase Cancer Center:
bladder
cancer
invasive
Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases
Ureteral Diseases
Doxorubicin
Liposomal doxorubicin
Methotrexate
Vinblastine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic