MelanomaPhase 2NCT00598507
Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma
A Phase 2 study testing ZK-EPO in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out how effective an investigational drug named ZK-Epo is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not approved for use in treating melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- ZK-EPO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 21Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
The purpose of this study is to find out how effective an investigational drug named ZK-Epo is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not approved for use in treating melanoma. This research is being done because currently there are only a limited number of treatment options for patients who have melanoma that has spread to distant organs.
We expect each patient to be in this study for at least 2 cycles. One cycle lasts for 21 days. If their tumor does not grow after 2 cycles and they do not have any major side-effects, they may receive up to 6 cycles of ZK-Epo.
If after they have received 6 cycles of ZK-Epo and their doctor determines that the tumor is continuing to shrink, they will continue treatment with ZK-Epo. The number of treatments the patient receives after 6 cycles will depend upon when their doctor feels there has been maximum tumor response (tumor shrinkage). Two treatments will be given beyond what their doctor considers the point of maximum shrinkage. We estimate that they will spend anywhere from 1 1/2 months to 5 months taking part in this study.
Read the detailed description
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.
- Conditions
- Melanoma
- Being tested
- ZK-EPO
- Keywords
- ZK-EPO, ZK219477, EpothiloneZK
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZK-EPODrug
Also called EpothiloneZK, ZK 219477, Sagopilone
Participants were treated with 16 mg/m^2 of ZK-EPO (EpothiloneZK) (Sagopilone) administered as a single 3 hour intravenous infusion every 21 days. Prior to each treatment, participants were premedicated with either granisetron or ondansetron and additional anti-emetics if needed. Chemotherapy was continued until disease progression, withdrawal of consent, or for unacceptable treatment-associated toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy - ZK-EPO | Experimental | ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity. Receives: Drug: ZK-EPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (RR)
Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Measured: Up to 5 years
Secondary outcomes (3)
Median Progression Free Survival (PFS)
PFS: the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD)according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Measured: Up to 5 years
Median Overall Survival (OS)
Median OS: the time (expressed in months or years) when half the patients are expected to be alive.
Measured: Up to 5 years
Occurrence of Attributable Serious Adverse Events (SAEs)
Number of participants with Grade 3 or higher adverse events, attributable to treatment with sagopilone.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Ronald DeConti, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598507
- Sponsor's protocol ID
- MCC-14965
- Other IDs
- ZK219477, 108.0701
- Status last verified
- Aug 2013
- First submitted
- 10 Jan 2008
- Last updated
- 11 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00598507
- Acronym / sponsor ID
- MCC-14965
- Conditions
- Melanoma
- Keywords
- ZK-EPO, ZK219477, EpothiloneZK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- May 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Jan 2008 (estimated)
- Results
- Posted 15 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out how effective an investigational drug named ZK-Epo is against melanoma. Although ZK-Epo has been studied in the treatment of cancer, it is not approved for use in treating melanoma. This research is being done because currently there are only a limited number of treatment options for patients who have melanoma that has spread to distant organs.
We expect each patient to be in this study for at least 2 cycles. One cycle lasts for 21 days. If their tumor does not grow after 2 cycles and they do not have any major side-effects, they may receive up to 6 cycles of ZK-Epo.
If after they have received 6 cycles of ZK-Epo and their doctor determines that the tumor is continuing to shrink, they will continue treatment with ZK-Epo. The number of treatments the patient receives after 6 cycles will depend upon when their doctor feels there has been maximum tumor response (tumor shrinkage). Two treatments will be given beyond what their doctor considers the point of maximum shrinkage. We estimate that they will spend anywhere from 1 1/2 months to 5 months taking part in this study.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy - ZK-EPO | Experimental | Drug: ZK-EPOZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZK-EPOAlso: EpothiloneZK, ZK 219477, SagopiloneParticipants were treated with 16 mg/m^2 of ZK-EPO (EpothiloneZK) (Sagopilone) administered as a single 3 hour intravenous infusion every 21 days. Prior to each treatment, participants were premedicated with either granisetron or ondansetron and additional anti-emetics if needed. Chemotherapy was continued until disease progression, withdrawal of consent, or for unacceptable treatment-associated toxicity. | Drug | Chemotherapy - ZK-EPO |
Primary outcome
Response Rate (RR)
Time frame: Up to 5 years
Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
3 secondary outcomes
Median Progression Free Survival (PFS)
Time frame: Up to 5 years
Median Overall Survival (OS)
Time frame: Up to 5 years
Occurrence of Attributable Serious Adverse Events (SAEs)
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald DeConti, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZK-EPO in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (RR) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.