Intervention: Paclitaxel
Trial phase: Phase 2
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 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.

nab-paclitaxel: 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).
Eligibility criteria:
Inclusion Criteria:

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

Exclusion Criteria:

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