Phase 2 N=51 Treatment

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

Myeloproliferative Disorder · Urothelial Carcinoma · Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00588666 ↗

Enrolled (actual)

Serious AEs

56.9%

Results posted

Jan 2016

Primary outcome: Primary: Evaluate the Time to Disease Progression — 6.5; 13.9 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bevacizumab (Drug); Carboplatin (Drug); Gemcitabine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluate the Time to Disease Progression	6.5; 13.9	—
SECONDARY The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.	49	—

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.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00588666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.