Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma

NCT00598507 | Completed Phase 2 Results DMC

• 3 other identifiers: MCC-14965ZK219477108.0701
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Melanoma

Keywords

ZK-EPO; ZK219477; EpothiloneZK

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 5 years

Secondary Outcomes (3)

• Median Progression Free Survival (PFS)

  Up to 5 years

• Median Overall Survival (OS)

  Up to 5 years

• Occurrence of Attributable Serious Adverse Events (SAEs)

  Up to 5 years

Study Arms (1)

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.

Drug: ZK-EPO

Interventions

ZK-EPO DRUG

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.

Also known as: EpothiloneZK, ZK 219477, Sagopilone

Chemotherapy - ZK-EPO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Bayer: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

sagopilone

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Ronald DeConti, M.D., Principal Investigator
• Organization: H. Lee Moffitt Cancer Center and Research Institute

ronald.deconti@moffitt.org

813-745-8466

Study Officials

• Ronald DeConti, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 22, 2008
• Study Start: May 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 11, 2013
• Results First Posted: November 15, 2013

Record last verified: 2013-08

Locations

US (1)