NCT02324608CompletedNot Applicable
A Pilot Study of Neoadjuvant Cetuximab in Advanced Squamous Cell Carcinomas of Skin (SCCS)
Rutgers, The State University of New Jersey2 sites in 1 country15 target enrollmentStarted: January 30, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Response Rate of Cetuximab by RECIST Criteria
Study Overview
Brief Summary
This pilot clinical trial studies the side effects and how well cetuximab before surgery works in treating patients with skin cancer that forms, grows, and spreads quickly and has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways be targeting certain cells. Giving cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the response rate of cetuximab by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with advanced squamous cell carcinoma of skin (SCCS).
II. To assess whether neoadjuvant cetuximab given in this patient population is both safe and feasible.
SECONDARY OBJECTIVES:
I. To measure the progression free and overall survival of patients with advanced SCCS who receive neoadjuvant cetuximab.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have untreated or relapsed SCCS that is considered to be aggressive and locally advanced by the following criteria: tumors 2 cm or more, tumors invading deep tissues such as muscle, cartilage or bone; tumors showing perineural invasion, and/or tumors metastatic to loco-regional lymph nodes; patients may have had prior surgical interventions or been treated with investigational agents with residual or recurrent disease
- •Patients must give informed consent
- •Patients must agree to pre- and post-treatment biopsies
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Estimated life expectancy of at least 12 weeks
- •Negative pregnancy test
Exclusion Criteria
- •Second primary malignancy only if treatment would interfere with the patient's participation in this trial in the opinion of the treating physician; clear exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix) and, 3) additional skin cancers that have been definitively treated by surgery and/or radiation; patients with chronic lymphocytic leukemia will be allowed if their blood counts are within acceptable hematologic parameters and if they are not currently requiring cytotoxic or biologic anticancer treatment (supportive treatment such as intravenous immunoglobulin [IVIG] is permitted)
- •Patients with distant organ metastases will not be included in this study
- •Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab or other agents used in the study
- •Women who are pregnant; women of childbearing age must agree to undergo a pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •Serum calcium (ionized or adjusted for albumin) < 8 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
- •Magnesium < 1.4 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels
- •Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels
- •Prior radiation therapy is not an exclusion however, patient must have documented progression at the radiation site
Outcomes
Primary Outcomes
Response Rate of Cetuximab by RECIST Criteria
Time Frame: Up to 2 years
A one-sided Binomial exact test will be used.
Secondary Outcomes
- Potential Markers of Response and/or Resistance to Cetuximab Therapy(Up to 2 years)
- Downstream Activation of Signaling Pathways Without a Known Driver, Including the EGFRpathway(Up to 2 years)
- Progression-free Survival(Up to 2 years)
- Overall Survival(Up to 2 years)
Investigators
Adam Berger, MD
Principal Investigator
Rutgers Cancer Institute of New Jersey
Study Sites (2)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell CancerMetastatic Skin Squamous Cell CarcinomaRecurrent Skin Squamous Cell CarcinomaNCT04428671Emory University14
Completed
Phase 2
Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)Liver MetastasesColorectal CancerNCT00153998Technische Universität Dresden135
Completed
Phase 2
Pre-op Rectal ChemoRad +/- CetuximabRectal CancerNCT00527111US Oncology Research139
Terminated
Early Phase 1
Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by SurgeryLiver MetastasesMucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the RectumRecurrent Colon CancerRecurrent Rectal CancerSignet Ring Adenocarcinoma of the ColonSignet Ring Adenocarcinoma of the RectumStage IV Colon CancerStage IV Rectal CancerNCT00835679National Cancer Institute (NCI)9
Completed
Not Applicable
Neoadjuvant Cetuximab, Fluorouracil, and Pelvic Irradiation in Treating Patients With Locally Advanced or Locally Recurrent Rectal CancerColorectal CancerNCT00084773Memorial Sloan Kettering Cancer Center28