AzTrials
AzTrials

Metastatic MelanomaPhase 2NCT01014351

Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

A Phase 2 study testing Paclitaxel, Carboplatin and Everolimus in people with Metastatic Melanoma, run by SCRI Development Innovations, LLC at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Paclitaxel, Carboplatin and Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
12 sitesUnited States
Study dates
Feb 2010to Aug 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 confirmed metastatic melanoma.
  • Stage III or IV disease that is not amenable to resection.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation.
  • ECOG Performance Status of 0 or 1.
  • Life expectancy ≥12 weeks.
  • No prior cytotoxic chemotherapy or targeted therapy. Immunotherapy is allowed (i.e., interleukin-2 or interferon).
Show all 20Show fewer
  • Adequate hematological function:
  • absolute neutrophil count (ANC) ≥1500/µL and
  • platelets ≥100,000/µL and
  • hemoglobin >9 g/dL
  • Adequate renal function: serum creatinine ≤2.0 mg/dL or calculated (measured) GFR ≥50 mL/min.
  • Adequate hepatic function:
  • serum bilirubin ≤1.5 x institutional upper limit of normal (ULN);
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or ≤5 × ULN in patients with documented liver metastases.
  • Normal PT, INR. Patients on coumadin anticoagulation are eligible if they are on a stable dose, with an INR in the therapeutic range.
  • Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can be included after initiation of appropriate lipid lowering medication.
  • Age ≥18 years.
  • Ability to swallow whole pills.
  • Patient must be accessible for treatment and follow-up.
  • Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Who cannot join

  • Previous treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus), paclitaxel, or carboplatin.
  • Treatment with any investigational agent ≤4 weeks of protocol treatment.
  • Patients currently receiving anticancer therapies or who have received anticancer therapies ≤3 weeks of the start of the study drug (including radiation therapy, immunotherapy).
  • Patients, who have had a major surgery or significant traumatic injury ≤4 weeks of start of study drug or patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
  • Patients receiving chronic, systemic treatment with corticosteroids (dose >10 mg daily of methylprednisolone or equivalent) or other immunosuppressive agents. Topical or inhaled steroids are allowed.
  • Immunization with attenuated live vaccine ≤1 week of study or anytime during study treatment period.
Show all 23Show fewer
  • Patients with active brain metastases are ineligible. Patients with treated brain metastases are eligible if (1) radiation therapy was completed ≥4 weeks prior to study entry; (2) surgery was completed ≥4 weeks prior to study entry; (3) follow-up scan shows no disease progression; and (4) patient does not require steroids.
  • Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
  • severely impaired lung function defined as a DLCO ≤50% of the normal predicted value and/or O2 saturation ≤88% at rest on room air.
  • symptomatic congestive heart failure of New York Heart Association Class III or IV.
  • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant disease.
  • uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN.
  • active (acute or chronic) uncontrolled severe infections.
  • liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • Active, bleeding diathesis.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • A known history of human immunodeficiency virus (HIV) seropositivity.
  • Known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
  • Use of St. John's Wort is prohibited. Drugs or substances (e.g., grapefruits, star fruits, seville oranges, and their juices and products), known to be inhibitors or inducers of the isoenzyme CYP3A4 should be avoided. Co-administration with substrates, inducers, or inhibitors of P glycoprotein should also be avoided.
  • Female patients who are pregnant or breastfeeding or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential [WOCBP] must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus.) WOCBP should continue to use effective contraception for 8 weeks after ending everolimus treatment.
  • Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  • History of noncompliance to medical regimens. Patients unwilling to, or unable to, comply with the protocol.
  • History of any other disease, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or a condition that may render the patient at high risk for treatment complications using these agents.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Hematology Oncology Clinic, LLP

    Baton Rouge, Louisiana, 70809

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Oncology Hematology of SW Indiana

    Evansville, Indiana, 47630

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Oncology Program

    Grand Rapids, Michigan, 49503

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Nebraska Methodist Cancer Center

    Omaha, Nebraska, 68114

Other trials in United States

About this study

Official title: A Phase II Study of Everolimus in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.

Keywords
Metastatic Melanoma, Everolimus, Paclitaxel, Carboplatin
Medical subject headings
Melanoma

What participants receive

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

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle

  • CarboplatinDrug

    Also called Paraplatin

    Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle

  • EverolimusDrug

    Also called RAD001, Afinitor

    Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle

Study groups in NCT01014351
Study groupRoleWhat they receive
Paclitaxel/Carboplatin/EverolimusExperimentalSystemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Everolimus

What is being measured

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

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: 18 months

Secondary outcomes (2)

  1. Overall Survival (OS)

    Overall survival (OS) is defined as the time from randomization until death from any cause.

    Measured: 18 months

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 18 months

Timeline

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

  1. First posted17 Nov 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionFeb 2012
  4. Study completionAug 2013

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01014351
Sponsor's protocol ID
SCRI MEL 19
Status last verified
Jan 2014
First submitted
16 Nov 2009
Last updated
26 Mar 2014
Data monitoring committee
No

Publications

  • Hauke RJ, Infante JR, Rubin MS, Shih KC, Arrowsmith ER, Hainsworth JD. Everolimus in combination with paclitaxel and carboplatin in patients with metastatic melanoma: a phase II trial of the Sarah Cannon Research Institute Oncology Research Consortium. Melanoma Res. 2013 Dec;23(6):468-73. doi: 10.1097/CMR.0000000000000014.

    PubMed 23969699

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and Everolimus in people with Metastatic Melanoma, run by SCRI Development Innovations, LLC at 12 sites 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 20 inclusion and 23 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: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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 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?

Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (PFS) (time frame: 18 months). 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 NCT01014351, which also lists 1 linked publication.

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 26 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in