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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint is progression-free survival (PFS) based on a blinded radiology assessment of response using RECIST response guidelines.

Outcome Time Frame:

Every 8 weeks

Safety Issue:

No

Principal Investigator

Evan Hersh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

CA033

NCT ID:

NCT00864253

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • Melanoma
  • Malignant
  • Abraxane
  • ABI-007
  • Dacarbazine
  • Dtic-Dome
  • Melanoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Colorado Cancer CenterDenver, Colorado  80262
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
University of MinnesotaMinneapolis, Minnesota  55455
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Saint Louis UniversitySt. Louis, Missouri  63104
Tower Cancer Research FoundationBeverly Hills, California  90211
Wayne State UniversityDetroit, Michigan  48202
Lakeland Regional Cancer CenterLakeland, Florida  33805
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Hope OncologyRichardson, Texas  75080
Indiana UniversityIndianapolis, Indiana  46202
Nevada Cancer InstituteLas Vegas, Nevada  89135
St. John's Medical ResearchSpringfield, Missouri  65807
Baptist Cancer InstituteJacksonville, Florida  32207
University of Southern California/Norris Cancer CenterLos Angeles, California  90033
Mary Crowley Research CenterDallas, Texas  75246
Loma Linda University Cancer CenterLoma Linda, California  92354
St. Luke'S Hospital & Health NetworkBethlehem, Pennsylvania  18015
Evergreen Hematology & OncologySpokane, Washington  99218
St. Mary's Medical CenterSan Francisco, California  94117
Atlantic Melanoma CenterMorristown, New Jersey  07960
San Diego Pacific Oncology and Hematology AssociatesEncinitas, California  92024
AZ Cancer CtrScottsdale, Arizona  85258
Genesis Cancer Ctr - Hot SpringsHot Springs, Arkansas  71913
University of Arkansa for Medical SciencesLittle Rock, Arkansas  72205
University of CA Los AngelesLos Angeles, California  90095
University of Miami Hospital and Clincs/SCCCMiami, Florida  33136
Waren Billhartz Cancer CenterMaryville, Illinois  62062
IA Blood and Cancer Care, PLCCedar Rapids, Iowa  52402
Piedmont HematologyWinston-Salem, North Carolina  27103
OH State University Arthur G. James Cancer HospitalColumbus, Ohio  43210
Integris Cancer Institute of OKOklahoma City, Oklahoma  73142
Univ of TX MD Anderson Cancer CtrHouston, Texas  77030
Univ of TX Med School at HoustonHouston, Texas  77030
Covenant Health System DBA Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410
Utah Cancer SpecialistSalt Lake City, Utah  84106
Univ. of Washington Medical Center/Seattle Cancer Care AllianceSeattle, Washington  98109