NCT01847326

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer

Completed Phase 1 Last updated 31 July 2024

What this trial tests

Phase 1 trial testing carboplatin in Recurrent Salivary Gland Cancer in 48 participants. Completed in 22 January 2024.

Timeline

26 March 2013

Primary endpoint
22 January 2024

22 January 2024

Quick facts

Lead sponsor	University of Chicago
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	26 March 2013
Primary completion	22 January 2024
Estimated completion	22 January 2024
Sites	1 location across United States

Drugs / interventions tested

• carboplatin (Carboplatin) — full drug profile →
• paclitaxel albumin-stabilized nanoparticle formulation
• fluorouracil — full drug profile →
• hydroxyurea — full drug profile →
• therapeutic conventional surgery
• radiation therapy
• hyperfractionated radiation therapy
• laboratory biomarker analysis — full drug profile →

Conditions studied

• Recurrent Salivary Gland Cancer — all drugs for Recurrent Salivary Gland Cancer →
• Recurrent Squamous Cell Carcinoma of the Hypopharynx — all drugs for Recurrent Squamous Cell Carcinoma of the Hypopharynx →
• Recurrent Squamous Cell Carcinoma of the Larynx — all drugs for Recurrent Squamous Cell Carcinoma of the Larynx →
• Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity — all drugs for Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity →

Sponsor

University of Chicago

Who can join

18 and older, any sex, with Recurrent Salivary Gland Cancer or Recurrent Squamous Cell Carcinoma of the Hypopharynx. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin followed by chemoradiation in treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by chemoradiation therapy may be an effective treatment for head and neck cancer.

Publications & conference data

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

1. Application of nanotechnology to cancer radiotherapy.
   Mi Y, Shao Z, Vang J, Kaidar-Person O, et al · · 2016 · cited 79× · PMID 28066513 · DOI 10.1186/s12645-016-0024-7
2. Approaches to Improve EPR-Based Drug Delivery for Cancer Therapy and Diagnosis.
   Subhan MA, Parveen F, Filipczak N, Yalamarty SSK, et al · · 2023 · cited 45× · PMID 36983571 · DOI 10.3390/jpm13030389
3. Future trends and emerging issues for nanodelivery systems in oral and oropharyngeal cancer.
   Irimie AI, Sonea L, Jurj A, Mehterov N, et al · · 2017 · cited 32× · PMID 28721037 · DOI 10.2147/ijn.s133219
4. Engineered Cancer Nanovaccines: A New Frontier in Cancer Therapy.
   Wang Y, Liu C, Fang C, Peng Q, et al · · 2024 · cited 24× · PMID 39347944 · DOI 10.1007/s40820-024-01533-y
5. Nano-Drug Delivery Systems in Oral Cancer Therapy: Recent Developments and Prospective.
   Zhang Y, Wu Y, Du H, Li Z, et al · · 2023 · cited 19× · PMID 38276483 · DOI 10.3390/pharmaceutics16010007
6. Nanomedicine for cancer patient-centered care.
   Sorrentino C, Ciummo SL, Fieni C, Di Carlo E. · · 2024 · cited 10× · PMID 39434967 · DOI 10.1002/mco2.767
7. Nanotheranostics-based Management of Head and Neck Cancer.
   Chavda VP, Balar PC, Patel SB. · · 2023 · cited 10× · PMID 36793352 · DOI 10.7150/ntno.81724
8. 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