First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/27/2018
Start Date:December 2010
End Date:June 2018

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Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: Hoosier Cancer Research Network GU10-147

The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel
as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.

OUTLINE: This is a multi-center study

Patients will be enrolled into one of two parallel cohorts:

- Cohort 1: impaired renal function AND poor performance status (cycle length = 28 days).
Everolimus 10 mg orally daily

- Cohort 2: impaired renal function OR poor performance status (cycle length = 28 days).
Everolimus 10 mg orally daily + IV Paclitaxel 80 mg/m2 on D1, 8, 15

Restaging evaluations will be performed after every 2 cycles.

Treatment will continue until disease progression or unacceptable toxicity.

Karnofsky performance status 60-70%

Life Expectancy: Not specified

Hematopoietic:

- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3

- Hemoglobin (Hgb) ≥ 9 g/dL

- Platelets ≥ 100 K/mm3

- INR ≤ 1.5 (Anticoagulants are allowed if target INR ≤ 1.5 on a stable dose of warfarin
or on a stable dose of Low molecular weight (LMW) heparin for at least 2 weeks prior to
registration for protocol therapy).

- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L

- Fasting triglycerides ≤ 2.5 x ULN.

- Fasting serum glucose < 1.5 x ULN

Hepatic:

- Bilirubin ≤ 1.5 x ULN

- Aminotransferases (AST and ALT) ≤ 2.5 x ULN (unless liver metastases, then ≤ 5 x ULN)

Renal:

- Calculated creatinine clearance of < 60 using the Cockcroft-Gault formula

Cardiovascular:

- No symptomatic congestive heart failure of New York heart Association Class III or IV.

- No unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction
within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any
other clinically significant cardiac disease.

Inclusion Criteria:

- Histological or cytological proof of transitional cell carcinoma (TCC) of the bladder,
urethra, ureter, or renal pelvis (urothelial carcinoma). Histology may be mixed, but
still requires a component of TCC.

- Measurable disease according to RECIST and obtained by imaging within 30 days prior to
registration for protocol therapy.

- Must be ineligible for cisplatin, based on the following, within 30 days prior to
registration for protocol therapy.

- Prior radiation therapy is allowed to < 25% of the bone marrow.

- Written informed consent and HIPAA authorization for release of personal health
information.

- Age > 18 years at the time of consent.

- Females of childbearing potential and males must be willing to use an effective method
of contraception (hormonal or barrier method of birth control; abstinence) from the
time consent is signed until 8 weeks after treatment discontinuation.

- Females of childbearing potential must have a negative pregnancy test within 7 days
prior to prior to registration for protocol therapy.

- Females must not be breastfeeding.

Exclusion Criteria:

- No prior chemotherapy for metastatic disease. Prior chemotherapy in the
neoadjuvant/adjuvant setting is allowed if completed at least 12 months prior to
registration for protocol therapy.

- No active CNS metastases or leptomeningeal metastases. Patients with neurological
symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.

- No prior malignancy is allowed except for adequately treated basal cell or adequately
treated squamous cell skin cancer, in situ cervical cancer, Gleason ≤ grade 7 prostate
cancers (treated definitively with no evidence of PSA progression), or other cancer
for which the patient has been disease-free for at least 5 years.

- No treatment with any anticancer therapy or investigational agent within 30 days prior
to registration for protocol therapy.

- No known hypersensitivity to any protocol treatment.

- No prior treatment with mTOR inhibitor (sirolimus, temsirolimus, everolimus).

- No history of immunization with attenuated live vaccines within one week prior to
registration for protocol therapy or during study period.

- No severely impaired lung function as defined as spirometry and DLCO that is 50% of
the normal predicted value and/or 02 saturation that is 88% or less at rest on room
air.

- No uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN.

- No active (acute or chronic) or uncontrolled severe infections.

- No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent
hepatitis.

- No known history of HIV seropositivity.

- No impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of everolimus (e.g., ulcerative disease,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel
resection).

- No active, bleeding diathesis.

- No history of major surgery (defined as requiring general anesthesia) or significant
traumatic injury within 30 days prior to registration for protocol therapy.
We found this trial at
11
sites
Omaha, Nebraska 68114
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Birmingham, AL
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Bloomington, Indiana 47403
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Charleston, South Carolina 29425
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Charleston, SC
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Chicago, IL
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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Indianapolis, Indiana 46219
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Indianapolis, IN
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New York, NY
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Norfolk, VA
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Wyoming, Michigan 49519
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Wyoming, MI
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