Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer

NCT00234494 | Completed Phase 2 Results DMC

• 1 other identifier: HOG GU04-75
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 11

Brief Summary

Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%, including some complete responses (CR), with minimal toxicity in patients with advanced bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced for use in combination with cytotoxic chemotherapy to delay time to disease progression in patients with metastatic solid tumors. This trial is designed to further assess the efficacy, safety and tolerability of this regimen in this patient population.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  \- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.

  36 months

Secondary Outcomes (3)

• Overall Survival Time

  36 months

• Estimate Response Rates

  36 months

• Duration of Response for Responding Patients

  36 months

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

Cisplatin + Gemcitabine + Bevacizumab

Drug: Cisplatin; Drug: Gemcitabine; Drug: Bevacizumab

Interventions

Cisplatin DRUG

Cisplatin 70 mg/m2, day 1

Single Group Assignment

Gemcitabine DRUG

Gemcitabine 1250 mg/m2, day 1 and 8

Single Group Assignment

Bevacizumab DRUG

Bevacizumab 15mg/kg, day 1

Single Group Assignment

Eligibility Criteria

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

You may qualify if:

• Previously untreated or relapsed locally advanced or metastatic transitional cell carcinoma of the bladder. (Patients with pathology showing ANY component of non-transitional cell histology are not eligible).
• Relapsed patients may have received prior chemotherapy ≥ one year prior to study registration as part of a neoadjuvant or adjuvant regimen and must not have had intervening therapy from the end of that treatment until study entry.
• Measurable disease as per RECIST.
• Prior radiation therapy, immunotherapy, cytokine, biologic or vaccine therapy must be greater than 28 days prior to being registered for protocol therapy,

You may not qualify if:

• No known central nervous system metastasis. (imaging of brain only required if clinically indicated)
• No prior organ allograft.
• No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
• No evidence of bleeding diathesis or coagulopathy.
• No history of serious, non-healing wound, ulcer or bone fracture
• No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to being registered for protocol therapy.
• No prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled after approval from the study chair.
• No major surgical procedure, open biopsy, or significant traumatic injury less than 28 days prior to being registered for protocol therapy.
• Patients are not eligible if the need for any major surgical procedure is anticipated during the course of the study.
• Any minor surgical procedures, fine needle aspirations or core biopsies must be greater than 7 days prior to being registered for protocol therapy except procedures to secure a vascular access device which must be greater than 7 days prior to the start of protocol therapy.

Sponsors & Collaborators

• Christopher Sweeney, MBBS: lead
• Genentech, Inc.: collaborator
• Eli Lilly and Company: collaborator
• Walther Cancer Institute: collaborator
• Hoosier Cancer Research Network: collaborator

Study Sites (11)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, 46202, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

AP&S Clinic

Terre Haute, Indiana, 47804, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Oncology Hematology Care, Inc.

Cincinnati, Ohio, 45242, United States

Location

Related Publications (1)

• Hahn NM, Stadler WM, Zon RT, Waterhouse D, Picus J, Nattam S, Johnson CS, Perkins SM, Waddell MJ, Sweeney CJ; Hoosier Oncology Group. Phase II trial of cisplatin, gemcitabine, and bevacizumab as first-line therapy for metastatic urothelial carcinoma: Hoosier Oncology Group GU 04-75. J Clin Oncol. 2011 Apr 20;29(12):1525-30. doi: 10.1200/JCO.2010.31.6067. Epub 2011 Mar 21.

  PMID: 21422406 RESULT

Related Links

• Hoosier Cancer Research Network Homepage

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Gemcitabine; Bevacizumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Principal Investigator
• Organization: Hoosier Cancer Research Network, Inc.

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Christopher Sweeney, M.B.B.S.

  Hoosier Oncology Group, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• 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 INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 7, 2005
• Study Start: November 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)