Melanoma (Skin)Phase 1/2NCT00811759
Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV Melanoma
A Phase 1/2 study testing sorafenib tosylate, temozolomide and gene expression analysis in people with Melanoma (Skin), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from… 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?
- sorafenib tosylate, temozolomide and gene expression analysis
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to May 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
DISEASE CHARACTERISTICS:
- Diagnosis of unresectable or metastatic melanoma
- Stage III or IV disease
- Previously treated or untreated metastatic disease
- At least one unidimensionally measurable lesion by RECIST criteria by scan or MRI
- No concurrent brain or CNS metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 9 g/dL
- PT, INR, and PTT < 1.5 times upper limit of normal (ULN)
- Transaminases < 2.5 times ULN (< 5 in the case of liver metastases)
- Amylase and lipase < 1.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Serum creatinine < 1.5 times ULN
- Normal respiratory, cardiac, and neurological function
- Not pregnant or nursing
- No history of any of the following cardiac conditions:
- NYHA class II-IV heart failure
- Coronary disease
- Myocardial infarction within the past 6 months
- Cardiac arrhythmia requiring treatment with something other than beta-blockers or digoxin
- Severe uncontrolled hypertension
- No severe active infection > grade 2
- No epilepsy requiring medical treatment
- No other cancer except for carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumors, or curatively treated cancer > 3 years ago
- No HIV or hepatitis B or C positivity
- No lactase or galactokinase deficiency, galactose intolerance, or disease accompanied by malabsorption of glucose or galactose
- No allergy to the study drugs or to dacarbazine
- Able to swallow medications
- No patients deprived of liberty
- No psychological, familial, social, or geographic conditions that would preclude clinical follow up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior organ transplantation
- No prior temozolomide or sorafenib tosylate
- More than 30 days since other prior antitumor chemotherapy, immunotherapy, hormonal therapy, or investigational agent
- More than 30 days since prior study drugs
- More than 3 weeks since prior radiotherapy
- More than 3 weeks since prior biological response modifiers (i.e., filgrastim [G-CSF])
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single Center, Uncontrolled Phase I/II Study Evaluating the Safety and Maximum Tolerated Dose of Daily Sorafenib Administered in Combination With Prolonged Temozolomide in Patients With Metastatic Melanoma
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, 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 temozolomide may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety profile and the maximum tolerated dose of sorafenib tosylate and temozolomide in patients with stage III-IV melanoma. (Phase I)
- Evaluate progression-free survival at 12 weeks. (Phase II)
Secondary
- Evaluate tumor response according to RECIST criteria.
- Evaluate overall and progression-free survival.
- Evaluate the effect of treatment on tumor vascularization.
- Compare the pharmacokinetic profile of temozolomide with and without sorafenib tosylate.
- Evaluate the number and the role of lymphocytes.
- Correlate tumor response rate with BRAF mutation status.
- Correlate response rate with MGMT activity.
- Compare the efficacy of genomics and proteomics as a means of discovery of serum biomarkers.
- Study the prognostic and predictive value of circulating endothelial cells and circulating endothelial progenitors.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 (days 8-28 of course 1) and oral temozolomide once daily on days 1-7 and 15-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with accessible tumors (cutaneous or sub-cutaneous) undergo biopsies at baseline and day 28 for analysis of BRAF mutations and MGMT expression.
- Conditions
- Melanoma (Skin)
- Being tested
- sorafenib tosylate, temozolomide, gene expression analysis, mutation analysis, laboratory biomarker analysis
- Keywords
- stage IV melanoma, stage III melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenib tosylateDrug
temozolomideDrug
gene expression analysisGenetic
mutation analysisGenetic
laboratory biomarker analysisOther
biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (Phase I)
Progression-free survival at 12 weeks (Phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startJun 2007
- Primary completionMay 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.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- Caroline Robert, MD, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811759
- Sponsor's protocol ID
- CDR0000626803
- Other IDs
- IGR-CSET-2006/1261, IGR-SORAF-TEM ST1, INCA-RECF0818, EUDRACT-2007-00527-18, SCHER-IGR-CSET-2006/1261, BAYER-IGR-CSET-2006/1261
- Status last verified
- Jul 2009
- First submitted
- 18 Dec 2008
- Last updated
- 7 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Center, Uncontrolled Phase I/II Study Evaluating the Safety and Maximum Tolerated Dose of Daily Sorafenib Administered in Combination With Prolonged Temozolomide in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00811759
- Acronym / sponsor ID
- CDR0000626803
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, stage III melanoma, recurrent melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2009 (estimated)
- First posted
- 19 Dec 2008 (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 and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, 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 temozolomide may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the safety profile and the maximum tolerated dose of sorafenib tosylate and temozolomide in patients with stage III-IV melanoma. (Phase I)
- Evaluate progression-free survival at 12 weeks. (Phase II)
Secondary
- Evaluate tumor response according to RECIST criteria.
- Evaluate overall and progression-free survival.
- Evaluate the effect of treatment on tumor vascularization.
- Compare the pharmacokinetic profile of temozolomide with and without sorafenib tosylate.
- Evaluate the number and the role of lymphocytes.
- Correlate tumor response rate with BRAF mutation status.
- Correlate response rate with MGMT activity.
- Compare the efficacy of genomics and proteomics as a means of discovery of serum biomarkers.
- Study the prognostic and predictive value of circulating endothelial cells and circulating endothelial progenitors.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 (days 8-28 of course 1) and oral temozolomide once daily on days 1-7 and 15-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with accessible tumors (cutaneous or sub-cutaneous) undergo biopsies at baseline and day 28 for analysis of BRAF mutations and MGMT expression.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| sorafenib tosylate | Drug | – |
| temozolomide | Drug | – |
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
| biopsy | Procedure or surgery | – |
Primary outcome
Maximum tolerated dose (Phase I)
Progression-free survival at 12 weeks (Phase II)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2010.
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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.
Caroline Robert, MD
Gustave Roussy, Cancer Campus, Grand Paris
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 sorafenib tosylate, temozolomide and gene expression analysis in people with Melanoma (Skin), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Oct 2010. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (Phase I). The study lists 2 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 7 Oct 2010.