Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery

NCT00738361 | Completed Phase 2 Results DMC

• 2 other identifiers: OSU-08076NCI-2011-03176
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.

Conditions

Intraocular Melanoma

Keywords

ciliary body and choroid melanoma, medium/large size; iris melanoma; metastatic intraocular melanoma; recurrent intraocular melanoma; extraocular extension melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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.

  up to 1 year following last treatment, for a total of approximately 5 years

Secondary Outcomes (2)

• Progression-free Survival

  up to 1 year following last treatment, for a total of approximately 5 years

• Overall Survival

  up to 1 year following last treatment, for a total of approximately 5 years

Study Arms (1)

nab-paclitaxel

EXPERIMENTAL

Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.

Drug: nab-paclitaxel

Interventions

nab-paclitaxel DRUG

150 mg/m2 weekly for 3 of 4 weeks every 28 days.

Also known as: Abraxane, paclitaxel protein-bound particles for injectable suspension

nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed evidence of metastatic/ unresectable uveal melanoma
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension and is ≥10 mm by spiral CT scan
• years or older
• Eastern Cooperative Oncology Group(ECOG)performance status 0, or 1
• No known HIV or Hepatitis B or C
• Patients with brain metastasis are eligible for entry into the study
• Patients must have normal organ/marrow function as defined below:
• Absolute neutrophil count ≥ 1.5 x 109/L
• Platelets ≥ 100,000 x 109/L
• Hemoglobin ≥ 9.0 gm/100 ml
• Total bilirubin ≤ 1.5. In patients with Gilbert's disease the indirect bilirubin must be less than or equal to 4.0.
• AST and ALT ≤ 2.5x upper limit of normal
• Alkaline phosphatase ≤ 2.5x upper limit of normal, unless bone metastases is present in the absence of liver metastasis
• Creatinine ≤ 1.8 mg/ml or calculated creatinine clearance \> 50 mg ml.
• Calcium \<12 mg/dl when corrected for levels of serum albumen

You may not qualify if:

• Chemotherapy or radiotherapy within 4 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier.
• May not be receiving any other simultaneous investigational agents
• No prior malignancy except for adequately treated basal cell cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years.
• Patients who have serious infections or other major uncontrolled medical illnesses.
• Patients who have significant psychiatric illness who in the opinion of the principal investigator would prevent adequate informed consent or render therapy unsafe.
• Patients who are pregnant. Female patients of child bearing potential must have a negative serum pregnancy test and use adequate contraception protection while on study.
• Peripheral neuropathy of \> grade 2.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Comprehensive Cancer Network: collaborator
• Celgene Corporation: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Uveal Melanoma

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Thomas Olencki, D.O.
• Organization: Ohio State University Comprehensive Cancer Center

Thomas.Olencki@osumc.edu

614-293-2886

Study Officials

• Thomas E. Olencki, DO

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 20, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: April 1, 2013
• Last Updated: February 12, 2016
• Results First Posted: February 12, 2016

Record last verified: 2016-01

Locations

US (1)