A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma

NCT00523640 | Terminated Phase 2 Results DMC

• 1 other identifier: 13662A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out what effects (good and bad) the combination of the chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney cancer.

Conditions

Carcinoma, Renal Cell

Keywords

metastatic; renal cell; kidney; neoplasm

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.

  12 weeks

• Progression-free Survival

  Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline

  60 months

Secondary Outcomes (1)

• Overall Survival

  60 months

Study Arms (1)

I

EXPERIMENTAL

Combination of gemcitabine, capecitabine, and bevacizumab gemcitabine 1000 mg/m\^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle

Drug: combination of gemcitabine, capecitabine, and bevacizumab

Interventions

combination of gemcitabine, capecitabine, and bevacizumab DRUG

gemcitabine 1000 mg/m\^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle

I

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed metastatic clear cell renal cell cancer
• Measurable disease
• Age 18 or older
• ECOG performance status of 0 - 1
• Blood pressure less than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart
• Normal organ function
• Women of child-bearing potential and men must agree to use adequate contraception
• Ability to understand and the willingness to sign a written informed consent document and to follow all required study procedures

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not have had prior treatment with pyrimidine analogs or VEGF binding agents
• Patients may not be receiving any other investigational or therapeutic agents
• Patients may not be receiving therapeutic anticoagulation with warfarin, its congeners, heparin, low molecular weight heparinoids, specific thrombin inhibitors, or other similar agents Patients receiving low dose coumadin (1 mg daily) for central line patency are eligible
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment start, or anticipation of need for major surgical procedure during the course of the study Fine needle aspirations or core biopsies within 7 days prior to treatment start are acceptable
• Serious, nonhealing wound, ulcer, or bone fracture
• Evidence of bleeding diathesis or coagulopathy
• Patients with known brain metastases
• Uncontrolled intercurrent illness
• Pregnant women
• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study

Sponsors & Collaborators

• University of Chicago: lead
• Genentech, Inc.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis; Neoplasms

Interventions

Capecitabine; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Trial was designed with a maximum target accrual of 55 patients. The trial was halted early because emerging data with VEGF inhibitors challenged clinical relevance of the study and availability of multiple therapies challenged accrual.

Results Point of Contact

• Title: Theodore Karrison, PhD
• Organization: University of Chicago

tkarrison@health.bsd.uchicago.edu

773-702-9326

Study Officials

• Walter Stadler, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: March 1, 2005
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 11, 2014
• Results First Posted: December 22, 2011

Record last verified: 2014-01

Locations

US (1)