Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition | Intervention | Phase |
---|---|---|
Myeloproliferative Disorder Urothelial Carcinoma Cancer |
Drug: Bevacizumab, Carboplatin, Gemcitabine |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma |
- Evaluate the time to disease progression; To define the safety of combination therapy with bevacizumab, gemcitabine, and carboplatin in patients with advanced/metastatic TCC. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To define the response rate of combination therapy with bevacizumab, gemcitabine, and carboplatin in patients with advanced/metastatic TCC. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Enrollment: | 51 |
Study Start Date: | May 2006 |
Study Completion Date: | December 2011 |
Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Treatment |
Drug: Bevacizumab, Carboplatin, Gemcitabine
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.
Other Names:
|
Detailed Description:
This is a phase II trial of gemcitabine, carboplatin, and bevacizumab in chemotherapy naïve patients with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to comply with study and/or follow-up procedures
- History of persistent gross hematuria
United States, New Jersey | |
Memoral Sloan Kettering Cancer Center | |
Basking Ridge, New Jersey, United States | |
Memorial Sloan-Kettering at Basking Ridge | |
Basking Ridge, New Jersey, United States, 07920 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center @ Suffolk | |
Commack, New York, United States, 11725 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 | |
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | |
Rockville Centre, New York, United States, 11570 | |
Memoral Sloan Kettering Cancer Center@Phelps | |
Sleepy Hollow, New York, United States |
Principal Investigator: | Dean Bajorin, MD | Memorial Sloan-Kettering Cancer Center |
Additional Information:
No publications provided
Responsible Party: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00588666 History of Changes |
Other Study ID Numbers: | 06-006 |
Study First Received: | December 26, 2007 |
Last Updated: | December 13, 2011 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
Myeloproliferative Disorder urinary bladder Cancer |
ureter renal pelvis chemotherapy |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Transitional Cell Myeloproliferative Disorders Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Gemcitabine Bevacizumab Carboplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on October 17, 2012