A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
- Registration Number
- NCT00864253
- Lead Sponsor
- Celgene
- Brief Summary
The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 529
- Histologically or cytologically confirmed cutaneous malignant melanoma with evidence of metastasis (Stage IV).
- No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Prior treatment with kinase inhibitors or cytokines is permitted.
- No prior adjuvant cytotoxic chemotherapy is permitted. Prior adjuvant therapy with interferon, Granulocyte-macrophage colony-stimulating factor (GM-CSF) and/or vaccines is permitted.
- Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta human chorionic gonadotropin (ß-hCG) within 72 hours prior to first study drug administration. If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
- No other current active malignancy within the past 3 years.
- Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion
- Patient has the following blood counts at Baseline:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells/L;
- platelets ≥ 100 x 10^9 cells/L;
- Hemoglobin (Hgb) ≥ 9 g/dL.
- Patient has the following blood chemistry levels at Baseline:
- Aspartate aminotransferase(AST) glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5x upper limit of normal range (ULN); ≤ 5.0 xULN if hepatic metastases present;
- total bilirubin ≤ ULN;
- creatinine ≤ 1.5 mg/dL.
- Lactate Dehydrogenase (LDH) ≤ 2.0 x ULNa
- Expected survival of > 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
- History of or current evidence of brain metastases, including leptomeningeal involvement.
- Patient has pre-existing peripheral neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.
- Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- Patient has a clinically significant concurrent illness.
- Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
- Patient is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. Marker studies or studies evaluating biological correlates are permitted.
- Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABI-007 ABI-007 Treatment Arm A (ABI-007): Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks. Dacarbazine Dacarbazine Treatment Arm B (dacarbazine): Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012 PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.
- Secondary Outcome Measures
Name Time Method Participant Survival Up to 38 months; Up to data cut off of 30 June 2012 Survival was defined as the time from the date of randomization to the date of death (any cause). Participants were censored at the last known time that they were alive.
Nadir for Platelet Count Measurements. Day 1 up to 106 weeks; up to data cut off 30 June 2012 Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.
Pharmacokinetic Parameters On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug Maximum study drug exposure 106 weeks; data cut off 30 June 2012 The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Nadir for White Blood Cells (WBCs) Measurements Day 1 up to 106 weeks; up to data cut off 30 June 2012 Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.
Summary of Treatment-emergent Adverse Events (AEs) Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012 A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE's were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale:
Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.Nadir for the Absolute Neutrophil Count (ANC) Measurements Day 1 up to 106 weeks; up to data cut off 30 June 2012 Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.
Nadir for the Hemoglobin Count Measurements Day 1 up to 106 weeks; up to data cut off 30 June 2012 Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.
Trial Locations
- Locations (111)
Loma Linda University Cancer Center
🇺🇸Loma Linda, California, United States
Mary Crowley Research Center
🇺🇸Dallas, Texas, United States
Royal Adelaide Hospital, Department of Medical Oncology
🇦🇺Adelaide, South Australia, Australia
Sydney West Cancer Trials Centre/Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal North Shore Hospital
🇦🇺Sydney, New South Wales, Australia
BC Cancer Agency-Fraser Valley Ctr.
🇨🇦Surrey, British Columbia, Canada
CHRU Hopital Claude Huriez
🇫🇷Lile Cedax, France
Hopital de 1 Archet 2
🇫🇷Nice Cedex 3, France
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
BCCA Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
The Ottawa Hospital Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Hopital Bichat
🇫🇷Paris, France
London Regional Cancer Program
🇨🇦London, Ontario, Canada
IST-Istituto Nazionale per la Ricera sul Cancro
🇮🇹Genova, GE, Italy
Hopital Sainte Marguerite
🇫🇷Marseille Cedex 9, France
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
CHU Hopital Saint Eloi
🇫🇷Montepellier Cedex 5, France
Universitaetsklinkum Tuebingen
🇩🇪Tuebingen, BW, Germany
Universitaetklinkum Koeln
🇩🇪Koln, Northwest, Germany
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Centre Leon Berad
🇫🇷Lyon, France
Medizinische Hochschuke Hannover
🇩🇪Hannover, NI, Germany
Azienda Ospedaliera Universitaria Sense
🇮🇹Siena, SI, Italy
Credit Valley Hospital
🇨🇦Missiauga, Ontario, Canada
Hopital Dypuytren-CHU de Limoges
🇫🇷Limoges cedex, France
Univ Hospital of North Staffordshire
🇬🇧Stroke On Kent, Staffs, United Kingdom
H Clinic i Provincial
🇪🇸Barcelona, Spain
Hopital Saint-Louis
🇫🇷Paris Cedex, France
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, Nott, United Kingdom
Universitaetsklinkum Dresden
🇩🇪Dresden, SN, Germany
St. Josef-Hospital
🇩🇪Bochum, Northwest, Germany
Royal Marsden Hospital London
🇬🇧London, United Kingdom
Universitaetsklinkum Hamburg-Eppendorf
🇩🇪Hamburg, HH, Germany
Rijnstate ziekenhuis Arnhem
🇳🇱Amhem, Netherlands
Hopital Saint Andre' CHU de Bordeaux
🇫🇷Bordeaux, France
Singleton Hospital, Sothwest Wales Inst.
🇬🇧Swansea, S Glam, United Kingdom
Newcross Hospital
🇬🇧Wolverhampton, Wstmid, United Kingdom
H Clinico San Carlos
🇪🇸Madrid, Spain
Universitaetsklinkum Essen
🇩🇪Essen, Northwest, Germany
UniversitawtsklinKum Jena
🇩🇪Jena, Strasse 35, Germany
Istituto Europeo di Oncologia
🇮🇹Milano, MI, Italy
St. George's Hospital
🇬🇧London, GT Lon, United Kingdom
Universitaetsklinkum Heidelberg
🇩🇪Heidelber, BW, Germany
H CLINIC I Provincial
🇪🇸Barcelona, Spain
Universitaetsklinkum Wuerzburg PS
🇩🇪Wuerzburg, BY, Germany
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, BE, Germany
Corporacion Sanitaria Parc Tauli
🇪🇸Sabadell, Spain
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Velindre Hospital
🇬🇧Cardiff, Glam, United Kingdom
Sir Charles Gairdner Hospital
🇦🇺Nedlands Perth, Western Australia, Australia
Broomfield Hospital
🇬🇧Chelmsford, Essex, United Kingdom
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
San Diego Pacific Oncology and Hematology Associates
🇺🇸Encinitas, California, United States
University of CA Los Angeles
🇺🇸Los Angeles, California, United States
University of Southern California/Norris Cancer Center
🇺🇸Los Angeles, California, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
University of Miami Hospital and Clincs/SCCC
🇺🇸Miami, Florida, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Waren Billhartz Cancer Center
🇺🇸Maryville, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
IA Blood and Cancer Care, PLC
🇺🇸Cedar Rapids, Iowa, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
St. John's Medical Research
🇺🇸Springfield, Missouri, United States
Atlantic Melanoma Center
🇺🇸Morristown, New Jersey, United States
Piedmont Hematology
🇺🇸Winston-Salem, North Carolina, United States
OH State University Arthur G. James Cancer Hospital
🇺🇸Columbus, Ohio, United States
St. Luke's Hospital & Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Univ of TX MD Anderson Cancer Ctr
🇺🇸Houston, Texas, United States
Univ of TX Med School at Houston
🇺🇸Houston, Texas, United States
Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Hope Oncology
🇺🇸Richardson, Texas, United States
Univ. of Washington Medical Center/Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Evergreen Hematology & Oncology
🇺🇸Spokane, Washington, United States
Port Macquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
St. Mary's Medical Center
🇺🇸San Francisco, California, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Integris Cancer Institute of OK
🇺🇸Oklahoma City, Oklahoma, United States
Utah Cancer Specialist
🇺🇸Salt Lake City, Utah, United States
Istituto Tumori "Giovanni Paolo II"
🇮🇹Bari, BA, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei T
🇮🇹Meldola, FC, Italy
Istituto Nazionale Tumori
🇮🇹Milano, MI, Italy
IOV-Instituto Oncologico IRCCS
🇮🇹Padova, PD, Italy
Ist. Naz. per lo studio e la cura dei tumori G. Pascale
🇮🇹Napoli, Italy
Ospedale S. Chiara
🇮🇹Pisa, Italy
Genesis Cancer Ctr - Hot Springs
🇺🇸Hot Springs, Arkansas, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Centre Hospitaller Universitaire de Grenoble
🇫🇷Grenoble Cedex 09, France
Centre Regional Val d' Aurelle Paul Lamarque
🇫🇷Montpellier, France
Groupe hospitalier Cochin-St. Vincent de Paul
🇫🇷Paris, France
Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc
🇫🇷Villejuif Cedex, France
BCCA, Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
BC Cancer Agency-Vancouver Island Ctr.
🇨🇦Victoria, British Columbia, Canada
Weston Park Hospital
🇬🇧Sheffield, Syorks, United Kingdom
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
AZ Cancer Ctr
🇺🇸Scottsdale, Arizona, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
BC Cancer Agency-Vancouver
🇨🇦Vancouver, British Columbia, Canada
McGill University Dept. of Oncology Clinical Research Program
🇨🇦Montreal, Quebec, Canada
Erasmus MC ae" Daniel den Hoed
🇳🇱Rotterdam, Netherlands
Univeritaetsklinkum Goettingen
🇩🇪Gottington, NI, Germany
Universitaetsklinkum Schegwig-Holstein
🇩🇪Keil, SH, Germany
Universitaesklinkum Leipzig
🇩🇪Leipzig, Germany
Universitaetsklinkum Mainz
🇩🇪Mainz, Germany
University of Arkansa for Medical Sciences
🇺🇸Little Rock, Arkansas, United States