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Malignant MelanomaPhase 3NCT00864253

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

A Phase 3 study testing ABI-007 and Dacarbazine in people with Malignant Melanoma, run by Celgene at 112 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
ABI-007 and Dacarbazine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
529 participants
Where
112 sitesin 9 countries
Study dates
23 Apr 2009to 12 Feb 2014
Phase
Phase 3
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 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
Show all 18Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

112 sites in 9 countries.

112 sites in 9 countries

United States38 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • St. Luke's Hospital & Health Network

    Bethlehem, Pennsylvania, 18015

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35243

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • IA Blood and Cancer Care, PLC

    Cedar Rapids, Iowa, 52402

  • OH State University Arthur G. James Cancer Hospital

    Columbus, Ohio, 43210

  • Mary Crowley Research Center

    Dallas, Texas, 75246

  • Wayne State University

    Detroit, Michigan, 48201

  • San Diego Pacific Oncology and Hematology Associates

    Encinitas, California, 92024

  • Genesis Cancer Ctr - Hot Springs

    Hot Springs, Arkansas, 71913

  • Univ of TX MD Anderson Cancer Ctr

    Houston, Texas, 77030

  • Univ of TX Med School at Houston

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • University of Arkansa for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Cancer Center

    Loma Linda, California, 92354

  • University of Southern California/Norris Cancer Center

    Los Angeles, California, 90033

  • University of CA Los Angeles

    Los Angeles, California, 90095

  • Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Waren Billhartz Cancer Center

    Maryville, Illinois, 62062

  • University of Miami Hospital and Clincs/SCCC

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Atlantic Melanoma Center

    Morristown, New Jersey, 07962

  • Integris Cancer Institute of OK

    Oklahoma City, Oklahoma, 73142

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19131

  • Hope Oncology

    Richardson, Texas, 75080

  • Utah Cancer Specialist

    Salt Lake City, Utah, 84106

  • St. Mary's Medical Center

    San Francisco, California, 94117

  • AZ Cancer Ctr

    Scottsdale, Arizona, 85258

  • Univ. of Washington Medical Center/Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Evergreen Hematology & Oncology

    Spokane, Washington, 99218

  • St. John's Medical Research

    Springfield, Missouri, 65807

  • Saint Louis University

    St Louis, Missouri, 63110

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Piedmont Hematology

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany16 sites

  • Charite Universitaetsmedizin Berlin

    Berlin, State of Berlin, 10117

  • St. Josef-Hospital

    Bochum, Northwest, 44791

  • Universitaetklinkum Koeln

    Cologne, Northwest

  • Universitaetsklinkum Dresden

    Dresden, Saxony

  • Universitaetsklinkum Essen

    Essen, Northwest

  • Univeritaetsklinkum Goettingen

    Gottington, Lower Saxony

  • Universitaetsklinkum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg

  • Medizinische Hochschuke Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinkum Heidelberg

    Heidelber, Baden-Wurttemberg

  • Universitaetsklinkum Heidelberg

    Heidelberg, Baden-Wurttemberg

  • UniversitawtsklinKum Jena

    Jena, Strasse 35, 07743

  • Universitaetsklinkum Schegwig-Holstein

    Keil, Schleswig-Holstein, 24105

  • Universitaesklinkum Leipzig

    Leipzig

  • Universitaetsklinkum Mainz

    Mainz

  • Universitaetsklinkum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinkum Wuerzburg PS

    Würzburg, Bavaria, 97080

Other trials in Germany

France13 sites

  • Hopital Saint Andre' CHU de Bordeaux

    Bordeaux, 33075

  • Centre Hospitaller Universitaire de Grenoble

    Grenoble, 38043

  • CHRU Hopital Claude Huriez

    Lile Cedax

  • Hopital Dypuytren-CHU de Limoges

    Limoges

  • Centre Leon Berad

    Lyon

  • Hopital Sainte Marguerite

    Marseille

  • CHU Hopital Saint Eloi

    Montepellier Cedex 5

  • Centre Regional Val d' Aurelle Paul Lamarque

    Montpellier, 34298

  • Hopital de 1 Archet 2

    Nice, 06200

  • Hopital Bichat

    Paris, 75018

  • Groupe hospitalier Cochin-St. Vincent de Paul

    Paris

  • Hopital Saint-Louis

    Paris

  • Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc

    Villejuif, 94805

Other trials in France

Canada12 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • BCCA Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • BCCA, Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Credit Valley Hospital

    Missiauga, Ontario, L5M 2N1

  • McGill University Dept. of Oncology Clinical Research Program

    Montreal, Quebec, H2W 1S6

  • The Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • BC Cancer Agency-Fraser Valley Ctr.

    Surrey, British Columbia, V3V 1Z2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • BC Cancer Agency-Vancouver

    Vancouver, British Columbia, V5Z4E6

  • BC Cancer Agency-Vancouver Island Ctr.

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Italy9 sites

  • Istituto Tumori "Giovanni Paolo II"

    Bari, BA

  • IST-Istituto Nazionale per la Ricera sul Cancro

    Genova, GE, 16132

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei T

    Meldola, FC, 47014

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

  • Istituto Nazionale Tumori

    Milan, MI

  • Ist. Naz. per lo studio e la cura dei tumori G. Pascale

    Naples, 80131

  • IOV-Instituto Oncologico IRCCS

    Padova, PD, 35128

  • Ospedale S. Chiara

    Pisa, 56100

  • Azienda Ospedaliera Universitaria Sense

    Siena, SI, 53100

Other trials in Italy

United Kingdom9 sites

  • Velindre Hospital

    Cardiff, GLAM, CF14 2TL

  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

  • St. George's Hospital

    London, GT Lon, SW12 ORE

  • Royal Marsden Hospital London

    London, SW3 6JJ

  • Nottingham University Hospitals NHS Trust

    Nottingham, NOTT, NG5 1PB

  • Weston Park Hospital

    Sheffield, Syorks, S10 2SJ

  • Univ Hospital of North Staffordshire

    Stroke on Kent, Staffs, ST4 6QB

  • Singleton Hospital, Sothwest Wales Inst.

    Swansea, S GLAM, SA28QA

  • Newcross Hospital

    Wolverhampton, Wstmid, SV10 0QP

Other trials in United Kingdom

Australia8 sites

  • Royal Adelaide Hospital, Department of Medical Oncology

    Adelaide, South Australia, 5000

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands Perth, Western Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065

  • Sydney West Cancer Trials Centre/Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Spain4 sites

  • H Clinic i Provincial

    Barcelona, 08036

  • H CLINIC I Provincial

    Barcelona

  • H Clinico San Carlos

    Madrid

  • Corporacion Sanitaria Parc Tauli

    Sabadell, 08208

Other trials in Spain

Netherlands3 sites

  • Medisch Centrum Alkmaar

    Alkmaar, 1815

  • Rijnstate ziekenhuis Arnhem

    Amhem, 6800TA

  • Erasmus MC ae" Daniel den Hoed

    Rotterdam

Other trials in Netherlands

About this study

Official title: An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

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.

Being tested
ABI-007, Dacarbazine
Keywords
Melanoma, Malignant, Abraxane, ABI-007, Dacarbazine, Dtic-Dome
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABI-007Drug

    Also called Abraxane

    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.

  • DacarbazineDrug

    Also called Dtic-Dome, DTIC-Dome

    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.

Study groups in NCT00864253
Study groupRoleWhat they receive
ABI-007ExperimentalTreatment 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.
Receives: Drug: ABI-007
DacarbazineActive comparatorTreatment 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.
Receives: Drug: Dacarbazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines

    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.

    Measured: Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012

Secondary outcomes (8)

  1. Participant Survival

    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.

    Measured: Up to 38 months; Up to data cut off of 30 June 2012

  2. Summary of Treatment-emergent Adverse Events (AEs)

    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.

    Measured: Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012

  3. Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug

    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.

    Measured: Maximum study drug exposure 106 weeks; data cut off 30 June 2012

  4. Nadir for the Absolute Neutrophil Count (ANC) Measurements

    Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.

    Measured: Day 1 up to 106 weeks; up to data cut off 30 June 2012

  5. Nadir for White Blood Cells (WBCs) Measurements

    Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.

    Measured: Day 1 up to 106 weeks; up to data cut off 30 June 2012

  6. Nadir for Platelet Count Measurements.

    Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.

    Measured: Day 1 up to 106 weeks; up to data cut off 30 June 2012

  7. Nadir for the Hemoglobin Count Measurements

    Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.

    Measured: Day 1 up to 106 weeks; up to data cut off 30 June 2012

  8. Pharmacokinetic Parameters

    Measured: On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2009 (estimated)
  2. Study start23 Apr 2009
  3. Primary completion1 Jun 2012
  4. Study completion12 Feb 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
529 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00864253
Sponsor's protocol ID
CA033
Status last verified
Oct 2019
First submitted
16 Mar 2009
Last updated
30 Oct 2019
Data monitoring committee
Yes

Publications

  • Hersh EM, Del Vecchio M, Brown MP, Kefford R, Loquai C, Testori A, Bhatia S, Gutzmer R, Conry R, Haydon A, Robert C, Ernst S, Homsi J, Grob JJ, Kendra K, Agarwala SS, Li M, Clawson A, Brachmann C, Karnoub M, Elias I, Renschler MF, Hauschild A. A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naive patients with metastatic melanoma. Ann Oncol. 2015 Nov;26(11):2267-74. doi: 10.1093/annonc/mdv324. Epub 2015 Sep 26.

    PubMed 26410620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABI-007 and Dacarbazine in people with Malignant Melanoma, run by Celgene at 112 sites in 9 countries.

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 18 inclusion and 7 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Germany, France, Canada, Italy and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Jun 2014). 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?

Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (time frame: Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00864253, which also lists 1 linked publication.

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 30 Oct 2019.

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