Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study

• Register: ClinicalTrials.gov
• Last refreshed on: 29 October 2012
• Main ID: NCT00462423
• Date of registration: 18/04/2007
• Primary sponsor: Lynn E. Spitler, MD
• Public title: Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study AbraxAvast
• Scientific title: Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study
• Date of first enrolment: April 2007
• Target sample size: 50
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00462423
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Lynn E. Spitler, MD
• Affiliation: Northern California Melanoma Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed, (surgically incurable or unresectable) stage III or IV
metastatic malignant melanoma..

- Must be chemo naïve. Surgical adjuvant therapy with interferon, vaccines, or
cytokines is permitted. Prior adjuvant therapy with chemotherapeutic agents is not
allowed. Prior therapy for metastatic disease that is not chemotherapy is allowed.
Must have discontinued prior allowable therapy at least 4 weeks prior to initiation
of dosing.

- A minimum of 1 measurable lesion according to RECIST criteria.

- ECOG performance status of 0-1.

- Age = 18 years.

- Adequate hematologic, renal and liver function as defined by laboratory values
performed within 14 days prior to initiation of dosing.

- Patients must have recovered from effects of major surgery.

- Women of childbearing potential should be using an effective method of contraception.
Women of childbearing potential must have a negative urine or serum pregnancy test
up to 28 days prior to commencement of dosing and be practicing medically approved
contraceptive precautions for at least 6 months after completion of treatment as
directed by their physician.

- Men should use an effective method of contraception during treatment and for at least
6 months after completion of treatment as directed by their physician.

- Must have recovered from all prior treatment-related toxicities to NCI CTCAE (v 3.0)
Grade of 0 or 1, except for toxicities not considered a safety risk such as alopecia.

- Before study entry, written informed consent must be obtained. Written informed
consent must be obtained from the patient prior to performing any study-related
procedures.

Exclusion Criteria:

- Prior systemic therapy for metastatic disease with chemotherapy.

- Psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule; those conditions should be
discussed with the patient before trial entry.

- Major surgery or radiation therapy within 4 weeks of starting the study treatment.

- Known CNS disease.

- Previous Grade 2 or higher sensory neuropathy

- NCI CTCAE (V 3.0) grade 3 hemorrhage within 4 weeks of starting the study treatment.

- History of or known spinal cord compression, or carcinomatous meningitis, or evidence
of symptomatic brain or leptomeningeal disease on screening CT or MRI scan.

- Any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.

- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade = 2.

- Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or
diastolic blood pressure > 100 mmHg on antihypertensive medications)

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- Concurrent treatment on another clinical trial. Supportive care trials or
non-treatment trials, e.g. QOL, are allowed.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and
in the judgment of the investigator would make the subject inappropriate for entry
into this study.

- Previous cancer (unless a DRS interval of at least 5 years) or concurrent
malignancies at other sites with the exception of surgically cured carcinoma in-situ
of the cervix and basal or squamous cell carcinoma of the skin.

- Known clinically uncontrolled infectious disease including HIV positivity or
AIDS-related illness.

- Pregnant or nursing. Use of effective means of contraception (men and women) in
subjects of child-bearing potential.

- New York Heart Association (NYHA) Grade II or greater congestive heart failure.

- Symptomatic peripheral vascular disease.

- Significant vascular disease (e.g. aortic aneurysm, aortic dissection).

- Evidence of bleeding diathesis or coagulopathy.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study

- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to Day 0

- Proteinuria at screening as demonstrated by urine dipstick for proteinuria = 2+
(patients discovered to have = 2+ proteinuria on dipstick urinalysis at baseline
should undergo a 24 hour urine collection and must demonstrate = 1g of protein in 24
hours to be eligible).

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to comply with study and/or follow-up procedures



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic Malignant Melanoma

Intervention(s)

Drug: Abraxane and Avastin

Primary Outcome(s)

Progression-free survival (PFS) at 4 months [Time Frame: April 2007 through December 2009]

Secondary Outcome(s)

Duration of Objective Response in patients with measurable lesions [Time Frame: April 2007 through December 2010]

Objective Response Rate (RR) in patients with measurable lesions Time to Objective Response [Time Frame: April 2007 through December 2009]

Overall survival (OS) [Time Frame: April 2007 through December 2010]

Progression-free survival [Time Frame: April 2007 through July 2010]

Safety and Tolerability of this combination [Time Frame: April 2007 through December 2010]

Secondary ID(s)

070223

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene Corporation

Genentech