Response Rate of Cetuximab by RECIST Criteria
Primary
· Up to 2 years
A one-sided Binomial exact test will be used.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Cetuximab) | 15 |
Last reviewed · How we verify
NCT02324608
Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer
Completed
NA
Results posted
Last updated 20 December 2023
What this trial tests
NA trial testing cetuximab in Recurrent Skin Cancer in 15 participants. Completed in 30 May 2023.
Timeline
30 January 2015
Primary endpoint
9 December 2020
9 December 2020
30 May 2023
Quick facts
| Lead sponsor | Rutgers, The State University of New Jersey |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 30 January 2015 |
| Primary completion | 9 December 2020 |
| Estimated completion | 30 May 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- cetuximab (cetuximab) — full drug profile →
- laboratory biomarker analysis — full drug profile →
Conditions studied
- Recurrent Skin Cancer — all drugs for Recurrent Skin Cancer →
- Squamous Cell Carcinoma of the Skin — all drugs for Squamous Cell Carcinoma of the Skin →
Sponsor
Rutgers, The State University of New Jersey
Who can join
18 and older, any sex, with Recurrent Skin Cancer or Squamous Cell Carcinoma of the Skin. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival
Secondary
· Up to 2 years
The estimation of progression-free survival will be performed by the Kaplan-Meier product limit method. Descriptive statistics for all outcome measures will be provided. To evaluate the association between variables, either chi-square test (categorical vs. categorical) or two sample t-test (categorical vs. continuous) or correlation (continuous vs. continuous) will be used depending upon the types of variables in comparison.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Cetuximab) | 4 |
Overall Survival
Secondary
· Up to 2 years
The estimation of overall survival will be performed by the Kaplan-Meier product limit method. Descriptive statistics for all outcome measures will be provided. To evaluate the association between variables, either chi-square test (categorical vs. categorical) or two sample t-test (categorical vs. continuous) or correlation (continuous vs. continuous) will be used depending upon the types of variables in comparison.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Cetuximab) | 8 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years after the last participant receives treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Cetuximab)
Serious: 2/15 (13%)
Deaths: 8/15
Serious adverse events (3 terms)
| Reaction | System | Treatment (Cetuximab) |
|---|---|---|
| Ear pain | Ear and labyrinth disorders | — |
| Lung infection | Infections and infestations | — |
| Anorexia | Metabolism and nutrition disorders | — |
Other adverse events (41 terms — click to expand)
| Reaction | System | Treatment (Cetuximab) |
|---|---|---|
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Hypertension | Vascular disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Eye disorders - Other, specify | Eye disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Rash pustular | Infections and infestations | — |
| Headache | Nervous system disorders | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Fatigue | General disorders | — |
| Chills | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Wound complication | Injury, poisoning and procedural complications | — |
| Hypotension | Vascular disorders | — |
| Dry eye | Eye disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
| Esophageal pain | Gastrointestinal disorders | — |
| Oral pain | Gastrointestinal disorders | — |
| Lung infection | Infections and infestations | — |
| Alkaline phosphatase increased | Investigations | — |
| Creatinine increased | Investigations | — |
| Weight loss | Investigations | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | — |
| Ear pain | Ear and labyrinth disorders | — |
Most-reported serious reactions: Ear pain, Lung infection, Anorexia.
Data from ClinicalTrials.gov NCT02324608 adverse events section.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cutaneous Squamous Cell Carcinoma: From Biology to Therapy.
Corchado-Cobos R, García-Sancha N, González-Sarmiento R, Pérez-Losada J, et al · · 2020 · cited 133× · PMID 32331425 · DOI 10.3390/ijms21082956 -
Skin cancer: understanding the journey of transformation from conventional to advanced treatment approaches.
Hasan N, Nadaf A, Imran M, Jiba U, et al · · 2023 · cited 117× · PMID 37803407 · DOI 10.1186/s12943-023-01854-3 -
Neoadjuvant Therapy for Non-melanoma Skin Cancer: Updated Therapeutic Approaches for Basal, Squamous, and Merkel Cell Carcinoma.
Zelin E, Zalaudek I, Agozzino M, Dianzani C, et al · · 2021 · cited 30× · PMID 33725197 · DOI 10.1007/s11864-021-00826-3 -
Understanding the squamous cell carcinoma immune microenvironment.
Saeidi V, Doudican N, Carucci JA. · · 2023 · cited 29× · PMID 36793738 · DOI 10.3389/fimmu.2023.1084873 -
Adjuvant therapy for high-risk cutaneous squamous cell carcinoma: 10-year review.
Newman JG, Hall MA, Kurley SJ, Cook RW, et al · · 2021 · cited 24× · PMID 34096664 · DOI 10.1002/hed.26767 -
Therapeutic Approaches for Non-Melanoma Skin Cancer: Standard of Care and Emerging Modalities.
Sol S, Boncimino F, Todorova K, Waszyn SE, et al · · 2024 · cited 16× · PMID 39000164 · DOI 10.3390/ijms25137056 -
Review of recent advances in managing periocular skin malignancies.
Trotier DC, Huang L, van Landingham SW, Burr AR, et al · · 2024 · cited 6× · PMID 38500654 · DOI 10.3389/fonc.2024.1275930 -
Systemic Therapy for Non-Melanoma Skin Cancers: Latest Advances.
Lessans S, O'Connell KA, Choe J. · · 2024 · cited 4× · PMID 38954315 · DOI 10.1007/s11912-024-01570-1
Verify or expand the search:
- PubMed search for NCT02324608
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02324608 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rutgers, The State University of New Jersey
- Last refreshed: 20 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02324608.
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