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

  Show 112 Study Locations
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 17, 2014