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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00110019




Registration number
NCT00110019
Ethics application status
Date submitted
3/05/2005
Date registered
4/05/2005
Date last updated
19/10/2015

Titles & IDs
Public title
Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Scientific title
A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in Patients With Unresectable Locally Advanced or Stage IV Melanoma
Secondary ID [1] 0 0
NCI-2012-02978
Secondary ID [2] 0 0
NCI-2012-02978
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mucosal Melanoma 0 0
Recurrent Melanoma 0 0
Stage IIIA Skin Melanoma 0 0
Stage IIIB Skin Melanoma 0 0
Stage IIIC Skin Melanoma 0 0
Stage IV Skin Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Paclitaxel
Other interventions - Pharmacological Study
Other interventions - Placebo
Treatment: Drugs - Sorafenib Tosylate

Experimental: Arm I (paclitaxel, carboplatin, sorafenib tosylate) - Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive sorafenib tosylate PO BID (approximately every 12 hours) on days 2-19.

Active Comparator: Arm II (carboplatin, paclitaxel, placebo) - Patients receive paclitaxel and carboplatin as in Arm I. Patients also receive placebo PO BID (approximately every 12 hours) on days 2-19.


Treatment: Drugs: Carboplatin
Given IV

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Treatment: Drugs: Paclitaxel
Given IV

Other interventions: Pharmacological Study
Correlative studies

Other interventions: Placebo
Given PO

Treatment: Drugs: Sorafenib Tosylate
Given PO

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.
Timepoint [1] 0 0
Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.
Secondary outcome [1] 0 0
Progression-free Survival - Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.
Timepoint [1] 0 0
Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry.
Secondary outcome [2] 0 0
Objective Response (Complete and Partial Response) Rate - Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters.
Timepoint [2] 0 0
Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.

Eligibility
Key inclusion criteria
- Histological or cytological confirmed melanoma that is metastatic or unresectable;
patients must have a history of cutaneous, mucosal or unknown primary site

- Patients who have received prior systemic cytotoxic chemotherapy for treatment of
melanoma are ineligible; the following groups are eligible with regard to prior
systemic therapy either in the adjuvant or metastatic disease setting:

- No prior therapy

- Immunotherapy consisting of interferon, interleukin-2, granulocyte macrophage
colony-stimulating factor (GM-CSF) or vaccine

- One prior investigational therapy (cannot be chemotherapy or an inhibitor of rat
sarcoma [Ras], serine/threonine kinase [Raf], or mitogen-activated protein kinase
kinase [MEK])

- NOTE: Chemotherapy given via isolated limb perfusion is allowed

- Prior radiation therapy is allowed; however, if radiation has been administered to a
lesion, there must be radiographic evidence of progression of that lesion in order for
that lesion to constitute measurable disease or to be included in the measured target
lesions

- All sites of disease must be evaluated within 4 weeks of registration; patients must
have measurable disease as defined by Response Evaluation Criteria in Solid Tumors
(RECIST)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- White blood count >= 3,000/mm^3

- Absolute granulocyte count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Serum creatinine =< 2.0 x upper limit of normal (ULN) or serum creatinine clearance
(CrCl) >= 40 ml/min (neither drug is cleared by the kidney)

- Total bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert's disease)

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (=< 5.0
ULN in the presence of liver metastases)

- International normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT)
within normal limits (patients who are on therapeutic anticoagulation with warfarin
should have documentation of a normal prothrombin time [PT]/PTT prior to initiating
that therapy)

- Patients must not have ocular melanoma

- Patients must have discontinued immunotherapy or radiation therapy at least 4 weeks
prior to initiation of treatment and recovered from adverse events due to those agents

- Patients must not receive any other investigational agents during the period on study
or the four weeks prior to initiation of treatment

- Patients must not have a history or clinical evidence of brain metastasis; patients
must be evaluated with a head magnetic resonance imaging (MRI) within 4 weeks prior to
enrollment

- Patients must not have other current malignancies, other than basal cell skin cancer,
squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in
situ of the breast; patients with other malignancies are eligible if they have been
continuously disease-free for >= 5 years prior to the time of randomization

- Patients must not have any evidence of bleeding diathesis

- Patients must not have a serious intercurrent illness including, but not limited to,
ongoing or active infection requiring parenteral antibiotics, clinically significant
cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction,
unstable angina), New York Heart Association grade II or greater congestive heart
failure, serious cardiac arrhythmia requiring medication, or grade II or greater
peripheral vascular disease within 1 year prior to study entry, or psychiatric
illness/social situations that would limit compliance with study requirements

- Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs
(phenytoin, carbamazepine or phenobarbital), rifampin or St. John's Wort

- Women must not be pregnant or breast-feeding

- All females of childbearing potential must have a blood test or urine study within 4
weeks prior to registration to rule out pregnancy

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; should a woman become pregnant while
participating in this study, she should inform her treating physician immediately; if
a man impregnates a woman while participating in this study, he should inform his
treating physician immediately as well

- Human immunodeficiency virus (HIV)-positive patients are excluded from the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney West Area Health Service-Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
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Connecticut
Country [6] 0 0
United States of America
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Delaware
Country [7] 0 0
United States of America
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Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
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Hawaii
Country [10] 0 0
United States of America
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Illinois
Country [11] 0 0
United States of America
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Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
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Michigan
Country [18] 0 0
United States of America
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Minnesota
Country [19] 0 0
United States of America
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Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
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New Hampshire
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
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United States of America
State/province [25] 0 0
New York
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United States of America
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Oregon
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
Country [36] 0 0
United States of America
State/province [36] 0 0
Vermont
Country [37] 0 0
United States of America
State/province [37] 0 0
Virginia
Country [38] 0 0
United States of America
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Washington
Country [39] 0 0
United States of America
State/province [39] 0 0
West Virginia
Country [40] 0 0
United States of America
State/province [40] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to
see how well they work compared to carboplatin and paclitaxel in treating patients with stage
III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such
as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Sorafenib tosylate 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. It is not yet known whether giving carboplatin and
paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel
in treating melanoma.
Trial website
https://clinicaltrials.gov/show/NCT00110019
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keith Flaherty
Address 0 0
ECOG-ACRIN Cancer Research Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications