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An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma


OBJECTIVES:

Primary

- Determine the antitumor activity of ABI-007 in patients with inoperable locally
recurrent or metastatic melanoma.

- Determine the safety and tolerability of this drug in these patients.

Secondary

- Determine the time to disease progression, in terms of the rate and duration of
response or stable disease, in patients treated with this drug.

- Determine the survival of patients treated with this drug.

- Determine the effects of this drug on biomarkers of melanoma in these patients.

- Correlate biomarker levels with response in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment
cohorts according to prior cytotoxic chemotherapy (previously treated vs
chemotherapy-naïve).

- Cohort I (previously treated): Patients receive ABI-007 IV over 30 minutes on days 1,
8, and 15.

- Cohort II (chemotherapy-naïve): Patients receive a higher dose of ABI-007 as in cohort
I.

In both cohorts, courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.

Patients are followed monthly for 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per cohort) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed melanoma

- Inoperable locally recurrent or metastatic disease

- Measurable disease

- No lytic or blastic bone metastasis as only evidence of metastasis

- Prior radiotherapy to a target lesion allowed provided there has been clear
progression of disease since completion of radiotherapy

- No active brain metastasis, including leptomeningeal involvement

- Prior brain metastasis allowed provided the disease is in complete remission for
at least 1 month after therapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- More than 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

Hepatic

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the
absence of liver metastasis)

- Bilirubin ≤ 1.5 mg/dL

Renal

- Creatinine ≤ 1.5 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception 1 month before and during
study participation

- No pre-existing peripheral neuropathy ≥ grade 2

- No prior allergy or hypersensitivity to study drug

- No concurrent clinically significant illness

- No other concurrent active malignancy

- No serious medical risk factors involving any of the major organ systems that would
preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Recovered from prior chemotherapy

- More than 4 weeks since prior cytotoxic chemotherapy

- At least 3 weeks since prior anthracyclines

- No concurrent taxane or anthracyclines

- No concurrent doxorubicin

Endocrine therapy

- No concurrent steroids except as needed for hypersensitivity to study drug

Radiotherapy

- See Disease Characteristics

- Concurrent radiotherapy to a symptomatic non-target lesion (including recurrent or
new brain metastases that develop during study participation) allowed

Surgery

- Not specified

Other

- More than 4 weeks since prior investigational drugs and recovered

- No other concurrent anticancer therapy

- No concurrent participation in another clinical study

- No other concurrent investigational therapies

- No concurrent ritonavir, saquinavir, indinavir, or nelfinavir

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Antoni Ribas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000358804

NCT ID:

NCT00081042

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage III melanoma
  • stage IV melanoma
  • Melanoma

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781