Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma

NCT00588666 | Completed Phase 2 Results

• 1 other identifier: 06-006
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 6

Brief Summary

Gemcitabine and carboplatin are two standard chemotherapy drugs used to treat tumors of the urothelial tract. These drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer. New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. One new class of drugs are called 'angiogenesis-inhibitors'. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Bevacizumab is an anti-angiogenic drug. In some other cancers such as colon cancer and lung cancer, combining bevacizumab with standard chemotherapy shrinks tumors in a greater proportion of patients and makes patients live longer than using standard chemotherapy alone. This has never been tested in urothelial cancer and we do not know if bevacizumab will have the same effects in this disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, carboplatin, and bevacizumab has on you and your cancer.

Conditions

Myeloproliferative Disorder; Urothelial Carcinoma; Cancer

Keywords

Myeloproliferative Disorder; urinary bladder; Cancer; ureter; renal pelvis; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Evaluate the Time to Disease Progression

  Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI, 92(3):205-216, 2000\]. Changes in only the largest diameter (uni-dimensional measurement) are used in the RECIST criteria.

  3 years

Secondary Outcomes (1)

• The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.

  3 years

Study Arms (1)

Bevacizumab, Carboplatin, Gemcitabine

EXPERIMENTAL

Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.

Drug: Bevacizumab; Drug: Carboplatin; Drug: Gemcitabine

Interventions

Bevacizumab DRUG

Bevacizumab, Carboplatin, Gemcitabine

Carboplatin DRUG

Bevacizumab, Carboplatin, Gemcitabine

Gemcitabine DRUG

Bevacizumab, Carboplatin, Gemcitabine

Eligibility Criteria

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

You may qualify if:

• Histologic documentation: diagnosis of transitional cell carcinoma of the bladder,urethra, ureter, or renal pelvis.
• Unresectable or metastatic disease
• Ineligible for cisplatin (or incurable with cisplatin)
• ≥ 4 weeks since prior RT
• Karnofsky Performance Status ≥ 60%
• Age ≥ 18 years of age
• Required Initial Laboratory Values: Absolute neutrophil count ≥ 1.2 x 109/L; Platelets ≥ 100 x 109/L; Bilirubin ≤ 1.5 times the upper limit of normal (x ULN) for the institution; Aspartate transaminase (AST) and alanine transaminase(ALT) ≤ 3.0 x ULN;Serum creatinine \< 2.0 or calculated creatinine clearance (CrCl) ≥ 30 mL/min

You may not qualify if:

• Prior treatment with systemic chemotherapy (prior intravesical therapy is permitted)
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
• Blood pressure of \>150/100 mmHg
• Unstable angina
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction within 6 months
• History of stroke within 6 months
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Presence of central nervous system or brain metastases
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0
• Anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
• Pregnant (positive pregnancy test) or lactating
• Albuminuria as demonstrated by a urinary albumin of greater or = to 1.0 g/24 hr at screening

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (6)

Memorial Sloan-Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York, United States

Location

Related Links

• Memorial Sloan-Kettering web site

MeSH Terms

Conditions

Myeloproliferative Disorders; Carcinoma, Transitional Cell; Neoplasms

Interventions

Bevacizumab; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Dean Bajorin
• Organization: Memorial Sloan Kettering Cancer Center

bajorind@mskcc.org

646-422-4333

Study Officials

• Dean Bajorin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 26, 2007
• First Posted: January 8, 2008
• Study Start: May 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 22, 2016
• Results First Posted: January 22, 2016

Record last verified: 2015-12

Locations

US (6)