A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00864253
First received: March 16, 2009
Last updated: August 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Drug: ABI-007
Drug: Dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • The primary efficacy endpoint is progression-free survival (PFS) based on a blinded radiology assessment of response using RECIST response guidelines. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary efficacy endpoint is patient survival. [ Time Frame: varies ] [ Designated as safety issue: No ]
  • Progression-free survival based on investigator assessment. [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Number (%) of patients who achieve an objective confirmed complete or partial response [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Number (%) of patients with stable disease for ≥ 16 weeks, or confirmed complete or partial response (i.e., total response) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Duration of response in responding patients. [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Correlation of SPARC and other molecular biomarkers with efficacy outcomes. [ Time Frame: varies ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent and treatment related adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Laboratory abnormalities. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Nadir of myelosuppression during study drug dosing. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • Incidence of patients experiencing dose modifications, dose interruptions, and/or premature discontinuation of study drug. [ Time Frame: varies ] [ Designated as safety issue: Yes ]
  • The pharmacokinetic parameters are the maximum plasma drug concentration (Cmax), the area under the plasma concentration versus time curve (AUC and AUCinf), the half-life of the apparent terminal portion of the concentration versus time curve (T1/2). [ Time Frame: cycle 1 day 1: ABI-007 arm only ] [ Designated as safety issue: No ]
  • The pharmacokinetic parameters also include the total body clearance (CL), and the volume of distribution (Vz). [ Time Frame: cycle 1 day 1: ABI-007 arm only ] [ Designated as safety issue: No ]

Enrollment: 529
Study Start Date: April 2009
Estimated Study Completion Date: March 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: Abraxane
Active Comparator: 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.
Drug: 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.
Other Name: Dtic-Dome, DTIC-Dome

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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, 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 (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 [see Section 8.3.1.1 for definition of measurable lesions]).
  • Patient has the following blood counts at Baseline:
  • ANC ≥ 1.5 x 109 cells/L;
  • platelets ≥ 100 x 109 cells/L;
  • Hgb ≥ 9 g/dL.
  • Patient has the following blood chemistry levels at Baseline:
  • AST (SGOT), ALT (SGPT) ≤ 2.5x upper limit of normal range (ULN); ≤ 5.0 xULN if hepatic metastases present;
  • total bilirubin ≤ ULN;
  • creatinine ≤ 1.5 mg/dL.
  • LDH ≤ 2.0 x ULNa
  • Expected survival of > 12 weeks.
  • 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.

Exclusion Criteria:

  • History of or current evidence of brain metastases, including leptomeningeal involvement.
  • Patient has pre-existing peripheral neuropathy of 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864253

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35243
United States, Arizona
AZ Cancer Ctr
Scottsdale, Arizona, United States, 85258
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Genesis Cancer Ctr - Hot Springs
Hot Springs, Arkansas, United States, 71913
University of Arkansa for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
San Diego Pacific Oncology and Hematology Associates
Encinitas, California, United States, 92024
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
University of CA Los Angeles
Los Angeles, California, United States, 90095
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
St. Mary's Medical Center
San Francisco, California, United States, 94117
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
University of Miami Hospital and Clincs/SCCC
Miami, Florida, United States, 33136
United States, Illinois
Waren Billhartz Cancer Center
Maryville, Illinois, United States, 62062
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
IA Blood and Cancer Care, PLC
Cedar Rapids, Iowa, United States, 52402
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. John's Medical Research
Springfield, Missouri, United States, 65807
Saint Louis University
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Jersey
Atlantic Melanoma Center
Morristown, New Jersey, United States, 07962
United States, North Carolina
Piedmont Hematology
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
OH State University Arthur G. James Cancer Hospital
Columbus, Ohio, United States, 43210
United States, Oklahoma
Integris Cancer Institute of OK
Oklahoma City, Oklahoma, United States, 73142
United States, Pennsylvania
St. Luke's Hospital & Health Network
Bethlehem, Pennsylvania, United States, 18015
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19131
United States, Texas
Mary Crowley Research Center
Dallas, Texas, United States, 75246
Univ of TX MD Anderson Cancer Ctr
Houston, Texas, United States, 77030
Univ of TX Med School at Houston
Houston, Texas, United States, 77030
Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
Hope Oncology
Richardson, Texas, United States, 75080
United States, Utah
Utah Cancer Specialist
Salt Lake City, Utah, United States, 84106
United States, Washington
Univ. of Washington Medical Center/Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Evergreen Hematology & Oncology
Spokane, Washington, United States, 99218
Australia, New South Wales
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia, 2444
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Sydney West Cancer Trials Centre/Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Royal Adelaide Hospital, Department of Medical Oncology
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands Perth, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA, Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BC Cancer Agency-Fraser Valley Ctr.
Surrey, British Columbia, Canada, V3V 1Z2
BC Cancer Agency-Vancouver
Vancouver, British Columbia, Canada, V5Z4E6
BC Cancer Agency-Vancouver Island Ctr.
Victoria, British Columbia, Canada, V8R 6V5
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital
Missiauga, Ontario, Canada, L5M 2N1
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University Dept. of Oncology Clinical Research Program
Montreal, Quebec, Canada, H2W 1S6
France
Hopital Saint Andre' CHU de Bordeaux
Bordeaux, France, 33075
Centre Hospitaller Universitaire de Grenoble
Grenoble Cedex 09, France, 38043
CHRU Hopital Claude Huriez
Lile cedax, France
Hopital Dypuytren-CHU de Limoges
Limoges cedex, France
Centre Leon Berad
Lyon, France
Hopital Sainte Marguerite
Marseille Cedex 9, France
CHU Hopital Saint Eloi
Montepellier Cedex 5, France
Centre Regional Val d' Aurelle Paul Lamarque
Montpellier, France, 34298
Hopital de 1 Archet 2
Nice Cedex 3, France, 06200
Hopital Bichat
Paris, France, 75018
Groupe hospitalier Cochin-St. Vincent de Paul
Paris, France
Hopital Saint-Louis
Paris Cedex, France
Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc
Villejuif Cedex, France, 94805
Germany
Charite Universitaetsmedizin Berlin
Berlin, BE, Germany, 10117
Universitaetsklinkum Heidelberg
Heidelber, BW, Germany
Universitaetsklinkum Heidelberg
Heidelberg, BW, Germany
Universitaetsklinkum Tuebingen
Tuebingen, BW, Germany, 72076
Universitaetsklinkum Wuerzburg PS
Wuerzburg, BY, Germany, 97080
Universitaetsklinkum Hamburg-Eppendorf
Hamburg, HH, Germany
Univeritaetsklinkum Goettingen
Gottington, NI, Germany
Medizinische Hochschuke Hannover
Hannover, NI, Germany, 30625
St. Josef-Hospital
Bochum, NW, Germany, 44791
Universitaetsklinkum Essen
Essen, NW, Germany
Universitaetklinkum Koeln
Koln, NW, Germany
Universitaetsklinkum Schegwig-Holstein
Keil, SH, Germany, 24105
Universitaetsklinkum Dresden
Dresden, SN, Germany
UniversitawtsklinKum Jena
Jena, Strasse 35, Germany, 07743
Universitaesklinkum Leipzig
Leipzig, Germany
Universitaetsklinkum Mainz
Mainz, Germany
Italy
Istituto Tumori "Giovanni Paolo II"
Bari, BA, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei T
Meldola, FC, Italy, 47014
IST-Istituto Nazionale per la Ricera sul Cancro
Genova, GE, Italy, 16132
Istituto Europeo di Oncologia
Milano, MI, Italy, 20141
Istituto Nazionale Tumori
Milano, MI, Italy
IOV-Instituto Oncologico IRCCS
Padova, PD, Italy, 35128
Azienda Ospedaliera Universitaria Sense
Siena, SI, Italy, 53100
Ist. Naz. per lo studio e la cura dei tumori G. Pascale
Napoli, Italy, 80131
Ospedale S. Chiara
Pisa, Italy, 56100
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815
Rijnstate ziekenhuis Arnhem
Amhem, Netherlands, 6800TA
Erasmus MC ae" Daniel den Hoed
Rotterdam, Netherlands
Spain
H CLINIC I Provincial
Barcelona, Spain
H Clinic i Provincial
Barcelona, Spain, 08036
H Clinico San Carlos
Madrid, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, Spain, 08208
United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom, CM1 7ET
Velindre Hospital
Cardiff, Glam, United Kingdom, CF14 2TL
St. George's Hospital
London, GT Lon, United Kingdom, SW12 ORE
Nottingham University Hospitals NHS Trust
Nottingham, Nott, United Kingdom, NG5 1PB
Singleton Hospital, Sothwest Wales Inst.
Swansea, S Glam, United Kingdom, SA28QA
Univ Hospital of North Staffordshire
Stroke on Kent, Staffs, United Kingdom, ST4 6QB
Weston Park Hospital
Sheffield, Syorks, United Kingdom, S10 2SJ
Newcross Hospital
Wolverhampton, Wstmid, United Kingdom, SV10 0QP
Royal Marsden Hospital London
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Celgene Corporation
University of Arizona
Investigators
Principal Investigator: Evan Hersh, MD University of Arizona
Study Director: Ileana Elias, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00864253     History of Changes
Other Study ID Numbers: CA033
Study First Received: March 16, 2009
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: Human Research Ethics Committee
New Zealand: Medsafe

Keywords provided by Celgene Corporation:
Melanoma
Malignant
Abraxane
ABI-007
Dacarbazine
Dtic-Dome

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Paclitaxel
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 23, 2014