Phase II Trial Of ZK-EPO (ZK 219477) In Metastatic Melanoma
18 Years
N/A
Both
Melanoma
Trial Information
Phase II Trial Of ZK-EPO (ZK 219477) In Metastatic Melanoma
Each Cycle is a 21 day period. On the first day of each cycle each patient will receive the
study drug, ZK-Epo, through an IV infusion over a 3 hour period. Patients will receive the
study drug only once every 21 day period.
At the start of each cycle patients will have the following tests:
- Patients will be asked questions about their medical history and health and undergo a
complete physical exam.
- Blood tests will be done to check blood cell count and organ functions (about 1
tablespoon of blood will be taken).
- Performance status tests (will determine patient's ability to perform everyday
functions).
- A nurse or doctor will ask patients how they are feeling and about any side effects
that patients may be having.
- Pre Study Visit: Blood test called lactate dehydrogenase (LDH) to check organ function.
Prothrombin time (PT) and an a partial thromboplastin time (PTT) to see if the
patient's blood clots normally. Electrocardiogram (EKG) (to measure the electrical
function of patient's heart). Pregnancy Test (IF APPLICABLE a woman of child bearing
age). Optional Tumor Biopsy (If indicated by patient's physician).
- Cycle 1, Day 1: Pharmacokinetics: special blood tests to measure the drug levels, LDH
- Cycle 1, Day 2 & 8: Pharmacokinetics
- Cycle 1, Day 15: EKG
- Cycle 2, DAY 1: LDH
- Cycle 3, DAY 1: LDH, PT & activated partial thromboplastin time (aPTT)
- Cycle 4, 5, & 6, and all subsequent cycles, Day 1: LDH
During the first cycle only patients will also need to come for a study visit on day 8 and
15. During these two visits, blood tests will be done again to check blood cell count and
organ functions. Patients will also be asked how they are feeling and about any side
effects that they may be having.
Computed tomography (CT) scans or a magnetic resonance imaging (MRI) will be done after
every 2 cycles that each patient completes on the study. These will be done to help the
doctor re-evaluate each patient's disease.
Patients may have some additional blood tests done if they are among the first 10 patients
taking part in this study. In this case they will have 9 samples of blood (each about a
teaspoonful) drawn from them at specifically timed intervals (at 30 minutes before the start
and at 30 minutes, 2 hour 55 minutes, 3 hour 10 minutes, 3 hour 30 minutes, 5 hour, 8 hour,
27 hour (+/- 1 hour) and 168 hour (+/- 4 hours) after the start of the ZK-Epo infusion) so
that we can better understand the level of this drug in the body and its metabolism in
people.
Inclusion Criteria:
- Histologically or cytologically confirmed Malignant Melanoma.
- Unresectable Stage III or Stage IV disease.
- At least 1 measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate function of major organs and systems as measured by the following criteria:
Bone Marrow:
- Hemoglobin ≥ 10 g/dL
- White blood count (WBC) ≥ 3,000/mm^3
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic:
- Bilirubin within 1.5 times normal limit
- aspartate transaminase (AST)/Alanine aminotransferase (ALT) ≤ 5 times the upper limit
of normal (ULN)
Renal:
- Creatinine ≤ 2 mg/dL
Cardiovascular:
- No New York Heart Association (NYHA) class III or IV Congestive heart failure
- No unstable angina pectoris
- No arrhythmia needing continuous treatment
Nervous system:
- No Grade ≥ 2 peripheral neuropathy
Exclusion Criteria:
- More than 2 previous chemotherapy regimens.
- Any prior treatment with Epothilones, Epothilone analogues, taxanes, or vinca
alkaloids.
- Any progressive central nervous system (CNS) metastatic disease. Patients with CNS
metastases may be allowed if stable for 8 weeks or more and patient is neurologically
intact and off of steroids. The stability must be documented by MRI/CT over a period
of 8 weeks or greater.
- Any radiotherapy, chemotherapy, or immunotherapy within 3 weeks prior to first dose
of ZK-Epo. If patients were previously on temozolomide with extended dose schedule,
they must be off 1 week prior to the first dose of ZK-Epo.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Participants' Response Rate (RR)
Outcome Description:
To determine the response rate in patients with metastatic melanoma treated with ZK-Epo at a 3-hour infusion of 16 mg/m^2
Outcome Time Frame:
6 Months
Safety Issue:
No
Principal Investigator
Ronald DeConti, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Institutional Review Board
Study ID:
MCC-14965
NCT ID:
NCT00598507
Start Date:
May 2007
Completion Date:
January 2013
Related Keywords:
- Melanoma
- ZK-EPO
- ZK219477
- EpothiloneZK
- Melanoma
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
