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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00404235
Other study ID # NCCTG-N057E
Secondary ID NCI-2012-02705CD
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2006
Est. completion date March 2010

Study information

Verified date September 2018
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery.


Description:

OBJECTIVES:

Primary

- Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) in patients with unresectable stage IV melanoma who have not received prior chemotherapy for their metastatic disease. (Cohort 1)

- Assess the safety and antitumor activity of this regimen in patients with unresectable stage IV melanoma who have received prior chemotherapy for their metastatic disease. (Cohort 2)

Secondary

- Describe the impact of this regimen on parameters of immune function and angiogenesis in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no).

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date March 2010
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed unresectable stage IV melanoma

- Measurable disease

- Must have formalin-fixed, paraffin-embedded tumor tissue available for secreted protein acidic and rich in cysteine (SPARC) analysis pre-treatment (Mayo Clinic patients must be willing to submit a repeat biopsy at time of tumor progression)

- Brain metastases allowed provided they were previously treated with no progression for = 3 months

- Patients with known brain metastases may receive concurrent steroid treatment

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy = 3 months

- Absolute neutrophil count = 1,500/mm^3

- Platelet count = 100,000/mm^3

- Hemoglobin = 9 g/dL (may be transfused to meet this requirement)

- Creatinine = 1.5 times upper limit of normal (ULN)

- Total bilirubin = 1.5 times ULN (elevated bilirubin allowed in patients with documented Gilbert's syndrome)

- AST = 2.5 times ULN

- Alkaline phosphatase = 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after completion of study therapy

- No uncontrolled intercurrent illness including, but not limited to, the following:

- Active infection

- Congestive heart failure (New York Heart Association class III-IV heart disease)

- No peripheral neuropathy = grade 2

- No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin previously treated with local resection only or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior therapy

- At least 4 weeks since prior radiotherapy

- At least 4 weeks since prior interferon or interleukin-2

- At least 4 weeks since prior chemotherapy (cohort 1 )

- No prior chemotherapy in the metastatic setting (cohort 2)

- No prior treatment for melanoma with any of the following agents:

- Platinum chemotherapy (e.g., carboplatin or cisplatin)

- Taxanes (e.g., paclitaxel or docetaxel)

- Paclitaxel albumin-stabilized nanoparticle formulation (ABI-007)

- No other concurrent chemotherapy

- No other concurrent investigational agents

- No concurrent radiotherapy, including palliative radiotherapy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
carboplatin

paclitaxel albumin-stabilized nanoparticle formulation


Locations

Country Name City State
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States McFarland Clinic, PC Ames Iowa
United States AnMed Cancer Center Anderson South Carolina
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States Rush-Copley Cancer Care Center Aurora Illinois
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States MeritCare Bemidji Bemidji Minnesota
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Bismarck Cancer Center Bismarck North Dakota
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States St. Joseph Medical Center Bloomington Illinois
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Graham Hospital Canton Illinois
United States Memorial Hospital Carthage Illinois
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States CCOP - Dayton Dayton Ohio
United States David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Mercy Capitol Hospital Des Moines Iowa
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States CCOP - Duluth Duluth Minnesota
United States Duluth Clinic Cancer Center - Duluth Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Green Bay Oncology, Limited - Escanaba Escanaba Michigan
United States Eureka Community Hospital Eureka Illinois
United States CCOP - MeritCare Hospital Fargo North Dakota
United States MeritCare Broadway Fargo North Dakota
United States Blanchard Valley Medical Associates Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Middletown Regional Hospital Franklin Ohio
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Galesburg Clinic, PC Galesburg Illinois
United States Galesburg Cottage Hospital Galesburg Illinois
United States Big Sky Oncology Great Falls Montana
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Sletten Cancer Institute at Benefis Healthcare Great Falls Montana
United States Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States Mason District Hospital Havana Illinois
United States St. Peter's Hospital Helena Montana
United States Hopedale Medical Complex Hopedale Illinois
United States Dickinson County Healthcare System Iron Mountain Michigan
United States Foote Memorial Hospital Jackson Michigan
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Franciscan Skemp Healthcare - La Crosse Campus La Crosse Wisconsin
United States Sparrow Regional Cancer Center Lansing Michigan
United States Southwest Medical Center Liberal Kansas
United States Cancer Resource Center - Lincoln Lincoln Nebraska
United States St. Mary Mercy Hospital Livonia Michigan
United States McDonough District Hospital Macomb Illinois
United States Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota
United States Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline Illinois
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Perry Memorial Hospital Princeton Illinois
United States Rapid City Regional Hospital Rapid City South Dakota
United States Reid Hospital & Health Care Services Richmond Indiana
United States Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Rutherford Hospital Rutherfordton North Carolina
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States Coborn Cancer Center Saint Cloud Minnesota
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States HealthEast Cancer Care at St. Joseph's Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States St. Margaret's Hospital Spring Valley Illinois
United States Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
United States St. John Macomb Hospital Warren Michigan
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States HealthEast Cancer Care at Woodwinds Health Campus Woodbury Minnesota
United States Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kottschade LA, Suman VJ, Amatruda T 3rd, McWilliams RR, Mattar BI, Nikcevich DA, Behrens R, Fitch TR, Jaslowski AJ, Markovic SN. A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma : a North Central — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor Response Rate, as Measured by RECIST Criteria The RECIST criteria will be used for response assessments. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. Up to 2 years
Secondary Survival Time Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. Up to 2 years
Secondary Time to Disease Progression Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. Up to 2 years
Secondary Duration of Response Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Up to 3 years
Secondary Number of Treatment Cycles Administered Number of treatment cycles administered is defined to be the number of treatment cycles administered until the patient is removed from treatment due to progression, toxicity, or refusal. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. Up to 2 years
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