Dose Dense MVAC for Muscle Invasive Bladder Cancer

NCT01031420 | Completed Phase 2 Results DMC

• 2 other identifiers: FER-GU-026NCI-2010-01910
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscle Invasive Bladder Cancer; High Risk Urothelial Carcinoma of the Upper Urinary Tracts

Keywords

bladder; cancer; invasive

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response at Cystectomy or Ureterectomy Following Preoperative Dose Dense MVAC

  complete response rate (pT0), as defined by pathologic staging at cystectomy or ureterectomy, following neoadjuvant DD-MVAC chemotherapy.

  Following completion of the 3rd/final cycle of chemotherapy (about week 9) by CT imaging and at time of surgery for pathologic response.

Secondary Outcomes (1)

• Toxicity Profile of Dose Dense MVAC Given in the Neoadjuvant Setting.

  Ongoing throughout treatment at each MD visit every 14 days.

Study Arms (1)

dose dense MVAC

EXPERIMENTAL

standard doses of MVAC given every 14 days x 3.

Drug: single arm dose dense MVAC

Interventions

single arm dose dense MVAC DRUG

standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.

Also known as: 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

dose dense MVAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (2)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• Plimack ER, Hoffman-Censits JH, Viterbo R, Trabulsi EJ, Ross EA, Greenberg RE, Chen DY, Lallas CD, Wong YN, Lin J, Kutikov A, Dotan E, Brennan TA, Palma N, Dulaimi E, Mehrazin R, Boorjian SA, Kelly WK, Uzzo RG, Hudes GR. Accelerated methotrexate, vinblastine, doxorubicin, and cisplatin is safe, effective, and efficient neoadjuvant treatment for muscle-invasive bladder cancer: results of a multicenter phase II study with molecular correlates of response and toxicity. J Clin Oncol. 2014 Jun 20;32(18):1895-901. doi: 10.1200/JCO.2013.53.2465. Epub 2014 May 12.

  PMID: 24821881 RESULT

Related Links

• Pubmed.gov

MeSH Terms

Conditions

Neoplasms

Interventions

Methotrexate; Sodium; merphos; Vinblastine; Doxorubicin; Cisplatin; Platinum

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Transition Elements

Results Point of Contact

• Title: Elizabeth Plimack
• Organization: Fox Chase Cancer Center

Elizabeth.Plimack@fccc.edu

215-728-3889

Study Officials

• Elizabeth Plimack, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 14, 2009
• Study Start: December 7, 2009
• Primary Completion: July 19, 2013
• Study Completion: August 7, 2013
• Last Updated: September 17, 2019
• Results First Posted: August 21, 2019

Record last verified: 2019-08

Locations

US (2)