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MelanomaPhase 2NCT01851408

Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma

A Phase 2 study testing sorafenib tosylate and temsirolimus in people with Melanoma and Recurrent Melanoma, run by National Cancer Institute (NCI).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II portion of the trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Recurrent Melanoma, Stage III Melanoma
What is being tested?
sorafenib tosylate and temsirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2006to Feb 2012
Phase
Phase 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

  • Histologically or cytologically confirmed melanoma, meeting 1 of the following criteria: recurrent or unresectable stage III disease, stage IV disease, non-choroidal origin.
  • Tumor must be accessible to biopsy unless appropriate tumor sample collection has occurred within the past 3 months and patient agrees to provide these samples for this study.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Bilirubin normal
  • Creatinine normal or creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
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  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment.
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib or temsirolimus.
  • No uncontrolled hypertension, defined as systolic blood pressure > 140 mm Hg on 2 separate days < 1 week prior to study entry OR diastolic pressure > 90 mm Hg on 2 separate days < 1 week prior to study entry.
  • No evidence of bleeding diathesis or coagulopathy.
  • No condition that would impair the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication; requirement for IV alimentation; or active peptic ulcer disease).
  • No uncontrolled illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness or social situations that would limit study compliance.
  • No traumatic injury within the past 3 weeks.
  • No more than 1 prior systemic chemotherapy regimen for metastatic melanoma (Phase II).
  • No prior sorafenib, temsirolimus, or any other agents targeting raf, vascular endothelial growth factor (VEGF)/VEGF receptor, or mTOR (Phase II).
  • No prior surgical procedures affecting absorption.
  • At least 3 weeks since prior major surgery.
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) for melanoma and recovered.
  • At least 4 weeks since prior radiotherapy and recovered.
  • Prior biologic or immunotherapeutic regimens allowed.
  • Prior regional chemotherapy regimens (e.g., isolated limb perfusion) allowed but only 1 prior regional chemotherapy regimen allowed if all target lesions are within the prior regional treatment field.
  • No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following: phenytoin, carbamazepine, phenobarbital, rifampin or Hypericum perforatum (St. John's wort).
  • No concurrent prophylactic hematopoietic colony-stimulating factors.
  • No other concurrent investigational agents.
  • No other concurrent anticancer agents or therapies for this cancer.
  • No concurrent full-dose anticoagulation (i.e., warfarin, IV heparin, or low-molecular weight heparin).
  • No concurrent grapefruit or grapefruit juice.
  • No concurrent combination antiretroviral therapy for HIV-positive patients.
  • Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin) allowed provided prothrombin time (PT) international normalized ratio (INR) < 1.1 times upper limits of normal (ULN).
  • Unidimensionally measurable disease >= 20 mm by conventional techniques or >= 10 mm by spiral computed tomography (CT) scan (longest diameter to be recorded) and margins of visible cutaneous metastatic lesions should be clearly defined and measured in at least one dimension as >= 10 mm.
  • No known brain metastases unless the following criteria are met: no radiographical evidence of recurrences in the brain >= 3 months after complete resection of the brain metastases, asymptomatic brain metastases stable for >= 3 months since whole-brain radiation therapy and/or stereotactic radiosurgery and must not require steroid for brain metastases.
  • White Blood Count (WBC) >= 3,000/mm³
  • Absolute neutrophil count >= 1,500/mm³
  • Platelet count >= 100,000/mm³
  • Serum cholesterol =< 350 mg/dL
  • Triglycerides =< 400 mg/dL
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 2.5 times upper limit of normal.
  • No peripheral neuropathy > grade 2.
  • At least 5 years since prior chemotherapy for other types of cancer.

Who cannot join

None listed.

About this study

Official title: Phase 2 Study of the Combination of BAY 43-9006 (Sorafenib) and CCI-779 (Temsirolimus) in Patients With Metastatic Melanoma

This phase II portion of the trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temsirolimus may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  • To evaluate the clinical activity, in terms of overall response rate (complete and partial response), of this regimen in these patients. (Phase II)
  • To evaluate the in vivo biological activity of this regimen in these patients.

SECONDARY OBJECTIVES:

  1. To determine the progression-free survival and overall survival of patients treated with this regimen.

II. To determine the safety and toxicity of this regimen in these patients.

III. To Determine the population pharmacokinetics of this regimen in these patients.

IV. To correlate tumor and blood biomarkers with clinical outcome in patients treated with this regimen.

OUTLINE: Upon completion of the multicenter, phase I, dose-escalation study followed to be followed by this phase II, open-label study.

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and oral sorafenib once or twice daily on days 1-28. Treatment course repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3-6 months.

Being tested
sorafenib tosylate, temsirolimus
Keywords
Sorafenib, Temsirolimus, Stage IV, recurrent, unresectable, non-choroidal origin, CCI-779, BAY43-9006, metastatic melanoma
Medical subject headings
Melanoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given orally

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

Study groups in NCT01851408
Study groupRoleWhat they receive
Temsirolimus + SorafenibExperimentalTemsirolimus intravenous (IV) over 30 minutes on days 1, 8,15, and 22 and oral sorafenib once or twice daily on days 1-28.
Receives: Drug: sorafenib tosylate; Drug: temsirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (complete response and partial response) CCI-779 in combination with BAY43-9006

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Progression-free survival

    Kaplan-Meier life table methods and Cox proportional hazards regression modeling will be utilized to analyze progression-free survival and overall survival.

    Measured: The duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress, assessed up to 5 years

  2. Overall survival

    Kaplan-Meier life table methods and Cox proportional hazards regression modeling will be utilized to analyze progression-free survival and overall survival.

    Measured: 5 years

  3. Noncompartmental pharmacokinetic parameters of BAY43-9006 and CCI-779 estimated using a validated commercial software

    Maximum concentration (Cmax) and time to Cmax (tmax) will be the observed values. Area under the plasma concentration-time curve from zero to last observable time (AUClast).

    Measured: Week 1 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2013 (estimated)
  2. Study startApr 2006
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Why it stopped: No progression of Phase 1 trial to Phase 2.

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01851408
Sponsor's protocol ID
CDR0000480157
Other IDs
2005-0215, N01CM62202, NCI-2009-00131
Status last verified
May 2013
First submitted
9 May 2013
Last updated
15 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate and temsirolimus in people with Melanoma and Recurrent Melanoma, run by National Cancer Institute (NCI).

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 40 inclusion and 0 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: withdrawn, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Objective response rate (complete response and partial response) CCI-779 in combination with BAY43-9006 (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01851408.

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 15 Apr 2015.

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