Melanoma (Skin)Phase 1/2NCT00538005
Sorafenib, Bevacizumab, and Oxaliplatin in Treating Patients With Metastatic Malignant Melanoma
A Phase 1/2 study testing bevacizumab, oxaliplatin and sorafenib tosylate in people with Melanoma (Skin), run by San Diego Pacific Oncology & Hematology Associates at 1 site in United States.
Trial summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- bevacizumab, oxaliplatin and sorafenib tosylate
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jul 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 1,200/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
- Bilirubin ≤ 3.0 mg/dL
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- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- EKG with no evidence of serious arrhythmia or recent myocardial infarction
- See Disease Characteristics
- At least 6 weeks since prior radiotherapy
- More than 4 weeks since prior surgery
- Prior biologic therapy allowed
Who cannot join
- Active infection
- Chronic underlying immunodeficiency disease
- Other serious concurrent illness
- Other forms of cancer within 5 years of initial diagnosis except nonmelanoma skin cancer and cervical cancer
- Congestive heart failure or myocardial infarction within the past 6 months
- PRIOR CONCURRENT THERAPY:
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- Prior cytotoxic agents
- Prior sorafenib tosylate, bevacizumab, or oxaliplatin
- Concurrent biological therapy, except growth factors for anemia, neutropenia, or thrombocytopenia
- Concurrent radiotherapy, chemotherapy, or surgery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
Encinitas, California, 92024
Edward F. McClay, MD, 760-452-3340, emcclay@pacificoncology.com
About this study
Official title: A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of malignant melanoma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with bevacizumab and oxaliplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side-effects and best dose of sorafenib when given together with bevacizumab and oxaliplatin and to see how well it works in treating patients with metastatic malignant melanoma.
Read the detailed description
OBJECTIVES:
- To determine the maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin.
- To determine the effect of this treatment regimen on the complete and partial response rate in patients with metastatic melanoma.
- To determine the effect of this treatment regimen on the progression-free and overall survival of patients with metastatic melanoma.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase II study.
- Phase I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive oral sorafenib tosylate twice daily on days 1-14. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
- Phase II: Patients receive sorafenib tosylate at the maximum tolerated dose and bevacizumab and oxaliplatin as in phase I.
After completion of study therapy, patients are followed for at least 5 years.
- Conditions
- Melanoma (Skin)
- Being tested
- bevacizumab, oxaliplatin, sorafenib tosylate
- Keywords
- recurrent melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
oxaliplatinDrug
sorafenib tosylateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin
Response (complete and partial) as assessed by RECIST criteria
Progression-free survival
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego Pacific Oncology & Hematology Associates
- Sponsor type
- University, hospital or other
- Investigators
- Edward F. McClay, MD, Principal investigator, San Diego Pacific Oncology & Hematology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538005
- Sponsor's protocol ID
- CDR0000551557
- Other IDs
- POHA-0603
- Status last verified
- Jul 2009
- First submitted
- 1 Oct 2007
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00538005
- Acronym / sponsor ID
- CDR0000551557
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- San Diego Pacific Oncology & Hematology AssociatesUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2009 (estimated)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of malignant melanoma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with bevacizumab and oxaliplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side-effects and best dose of sorafenib when given together with bevacizumab and oxaliplatin and to see how well it works in treating patients with metastatic malignant melanoma.
Detailed description
OBJECTIVES:
- To determine the maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin.
- To determine the effect of this treatment regimen on the complete and partial response rate in patients with metastatic melanoma.
- To determine the effect of this treatment regimen on the progression-free and overall survival of patients with metastatic melanoma.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase II study.
- Phase I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive oral sorafenib tosylate twice daily on days 1-14. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
- Phase II: Patients receive sorafenib tosylate at the maximum tolerated dose and bevacizumab and oxaliplatin as in phase I.
After completion of study therapy, patients are followed for at least 5 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 1,200/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
Key exclusion criteria (10 listed)
- Active infection
- Chronic underlying immunodeficiency disease
- Other serious concurrent illness
- Other forms of cancer within 5 years of initial diagnosis except nonmelanoma skin cancer and cervical cancer
- Congestive heart failure or myocardial infarction within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab | Biological | – |
| oxaliplatin | Drug | – |
| sorafenib tosylate | Drug | – |
Primary outcome
Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin
Response (complete and partial) as assessed by RECIST criteria
Progression-free survival
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
Encinitas, United States
Edward F. McClay, MD principal investigator
San Diego Pacific Oncology & Hematology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bevacizumab, oxaliplatin and sorafenib tosylate in people with Melanoma (Skin), run by San Diego Pacific Oncology & Hematology Associates at 1 site in United States.
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 14 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2014.