Treatment With Nab-paclitaxel in Cutaneous SCC

NCT02076243 | Terminated Phase 2 Results

• 1 other identifier: GCO 12-1697
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator initiated phase II study to assess the efficacy of a chemotherapy called nab-paclitaxel as first line cytotoxic chemotherapy in subjects with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (SCC). All subjects receive the treatment by vein weekly and receive the same dose of the treatment. The risk of developing cutaneous SCC is approximately 10% in a lifetime. The vast majority are treated surgically and do not recur. However a small percentage become unresectable over time or metastasize distantly in the body. Unresectable and metastatic cutaneous SCC has a poor prognosis and oncologists often choose a whole body therapy without the benefit of prospective efficacy data. Very little prospective investigation into the efficacy of specific chemotherapy regimens as a function of line of therapy has been performed in this patient population. Nab-paclitaxel is type of chemotherapy that has demonstrated activity in other types of cancer such as lung and head and neck cancers. The primary objective of this study is to determine the response rate (percentage of subjects with tumor shrinkage) to nab-paclitaxel treatment in subjects with cutaneous SCC who have not received cytotoxic chemotherapy in the unresectable or the metastatic settings.. Secondary objectives are the progression free survival (time until tumor starts to grow), safety, assessment of the percentage of subjects whose tumor expresses a protein called SPARC, and correlating the expression of SPARC with response to treatment. To determine if the tumor expresses SPARC part of a prior standard biopsy such as that performed to establish the diagnosis of SCC will be used. SPARC is a protein that is overexpressed in a range of different cancer types and may alter the environment around the tumor possibly in a way that may make the SCC more responsive to treatment with nab-paclitaxel.

Conditions

Cutaneous Squamous Cell Carcinoma

Keywords

cutaneous squamous cell carcinoma; SCC; abraxane; nab-paclitaxel; unresectable; metastatic

Outcome Measures

Primary Outcomes (1)

• Response Rate

  the percentage of subjects who develop Complete Response (CR) or Partial Response (PR)

  at week 8 post treatment

Secondary Outcomes (4)

• Median Progression Free Survival

  average 5 years

• Prevalence of SPARC Expression

  at baseline

• Treatment Response

  at week 8 post treatment

• Safety and Tolerability

  up to 5 years

Study Arms (1)

nab-paclitaxel

EXPERIMENTAL

weekly dosed nab-paclitaxel chemotherapy (days 1, 8 , 15 of a 28 day cycle) administered as an I.V. infusion over approximately 30 minutes. Dosage is determined by weight and height of participant.

Drug: nab-paclitaxel

Interventions

nab-paclitaxel DRUG

nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC).

Also known as: abraxane

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 confirmed unresectable locoregional or distantly metastatic squamous cell carcinoma arising from a cutaneous surface, lip, or ear. Basosquamous histology is eligible.
• ECOG PS 0 or 1
• Life expectancy of more than 4 months
• Adequate renal, hepatic, and bone marrow function:
• Patients must have adequate liver function: AST and ALT \< 2.5 X upper limit of normal, alkaline phosphatase \< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis, Bilirubin \< 1.5 mg/dL
• Patients must have adequate bone marrow function: Platelets \>100,000 cells/mm3, Hemoglobin \> 9.0g/dL, WBC \> 3,000 cells/mm3, and ANC \> 1,500 cells/mm3
• Patients must have adequate renal function: creatinine \<1.5 mg/dL
• Age \> 18 years old
• Women of childbearing potential and sexually active males must agree to use effective contraception during treatment and for three months after completing treatment
• Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential
• No previous or concurrent malignancy except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, treated grade 1 papillary bladder cancer, localized prostate cancer detected via biopsy only and being treated with "watchful waiting", or other cancers where the patient has no evidence of recurrence for more than 5 years
• Must be at least 28 days since surgical procedure and/or radiation therapy and at least 4 weeks since last treatment with targeted therapies such as cetuximab or immunotherapy.
• No significant inter-current illness such as serious infection requiring intravenous antibiotics.
• Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE v4.0)
• Ability to provide informed consent

You may not qualify if:

• Prior systemic cytotoxic chemotherapy for unresectable SCC. Prior adjuvant or neoadjuvant cytotoxic chemotherapy provided not within prior 28 days is allowed. Prior systemic therapies with a targeted agent (cetuximab) or immunotherapy in the setting of unresectable SCC (is allowed).
• Prior taxane based chemotherapy
• The presence of any CNS tumor that has not been stable for at least 3 months off of corticosteroids and confirmed by imaging.
• Prior major organ transplant or autoimmune disease requiring chronic immunosuppression
• Psychiatric illness or social situation that would preclude compliance.
• Active or chronic infection with HIV, hepatitis B or hepatitis C. Formal testing should be performed if clinical suspicion.
• Patients with New York Heart Association class II, III, or IV disease or arrhythmia requiring treatment (rate controlled Atrial fibrillation is allowed)
• Lack of measurable disease on imaging studies as defined by RECIST 1.
• Any condition that in the opinion of the treating physician is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk
• Known allergy to treatment medication

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Celgene Corporation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

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

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: Dr. Philip Friedlander
• Organization: Icahn School of Medicine at Mount Sinai

philip.friedlander@mssm.edu

212-824-8584

Study Officials

• Philip Friedlander, MD, PhD

  Icahn School of Medicine at Mount Sinai

  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: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 3, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 25, 2017
• Results First Posted: October 25, 2017

Record last verified: 2017-09

Locations

US (1)