NCT00736619

Phase I Study of Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

Completed Phase 1 Last updated 9 August 2016

What this trial tests

Phase 1 trial testing Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®) in HEAD & NECK Cancer in 25 participants. Completed in 1 August 2016.

Timeline

1 August 2008

Primary endpoint
1 August 2016

1 August 2016

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 August 2008
Primary completion	1 August 2016
Estimated completion	1 August 2016
Sites	5 locations across United States

Drugs / interventions tested

• Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)

Conditions studied

• HEAD & NECK Cancer — all drugs for HEAD & NECK Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

Adults 18 to 100, any sex, with HEAD & NECK Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To establish the phase II recommended dose of weekly intravenous albumin-bound paclitaxel (Abraxane®) given concurrently with weekly cetuximab + definitive radiation therapy (IMRT) for patients with HNSCC.
  Time frame: conclusion of study

Sponsor's own description

For patients with this type of cancer, one standard treatment option is cetuximab (Erbitux®) + radiation. We wish to study the addition of albumin-bound paclitaxel (Abraxane®) to this standard regimen of cetuximab + radiation. Albumin-bound paclitaxel and cetuximab both are chemotherapy drugs which are administered by vein.

Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells when given alone or in combination with chemotherapy. The purpose of this study is to establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab and radiation therapy. The investigators want to find out what effects, good and/or bad, the albumin-bound paclitaxel has on you and your head and neck cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanoparticles in Clinical Translation for Cancer Therapy.
   Mundekkad D, Cho WC. · · 2022 · cited 146× · PMID 35163607 · DOI 10.3390/ijms23031685
2. Albumin Nanovectors in Cancer Therapy and Imaging.
   Parodi A, Miao J, Soond SM, Rudzińska M, et al · · 2019 · cited 91× · PMID 31195727 · DOI 10.3390/biom9060218
3. Advances in nanomaterials for the diagnosis and treatment of head and neck cancers: A review.
   Yu C, Li L, Wang S, Xu Y, et al · · 2023 · cited 19× · PMID 37056270 · DOI 10.1016/j.bioactmat.2022.08.010
4. Phase I study of weekly nab-paclitaxel + weekly cetuximab + intensity-modulated radiation therapy (IMRT) in patients with stage III-IVB head and neck squamous cell carcinoma (HNSCC).
   Fury MG, Sherman EJ, Rao SS, Wolden S, et al · · 2014 · cited 18× · PMID 24496920 · DOI 10.1093/annonc/mdt579
5. Pharmacological impact of microRNAs in head and neck squamous cell carcinoma: Prevailing insights on molecular pathways, diagnosis, and nanomedicine treatment.
   Bhattacharjee B, Syeda AF, Rynjah D, Hussain SM, et al · · 2023 · cited 17× · PMID 37205904 · DOI 10.3389/fphar.2023.1174330
6. Nanotheranostics-based Management of Head and Neck Cancer.
   Chavda VP, Balar PC, Patel SB. · · 2023 · cited 10× · PMID 36793352 · DOI 10.7150/ntno.81724
7. Nanoparticle-Based Chemotherapy Formulations for Head and Neck Cancer: A Systematic Review and Perspectives.
   de Lima JM, Bonan PR, da Cruz Perez DE, Hier M, et al · · 2020 · cited 10× · PMID 33003387 · DOI 10.3390/nano10101938
8. Recent Advances in Metal-Based NanoEnhancers for Particle Therapy.
   Chuang YC, Wu PH, Shen YA, Kuo CC, et al · · 2023 · cited 9× · PMID 36985905 · DOI 10.3390/nano13061011