A Phase 1/2 interventional study of celecoxib and Carboplatin in Cancer, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-04-25.
Sponsored by University of Alabama at Birmingham · Phase 1/2, Interventional, and Treatment
This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck.
Treatment for this protocol consists of radiotherapy, 70.2Gy, at 1.8Gy qd, Monday through Friday.Celecoxib 400mg bid is taken during radiotherapy, starting 1 week before radiotherapy. Carboplatin IV, AUC 2.0, weekly for weeks 1 through 7,Paclitaxel 45 mg/m2, weekly for weeks 1 through 7, and Celecoxib 400mg bid, continuing after therapy for two years or until disease progression.
University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
The patient has:
Exclusion Criteria:
Drug: celecoxib · Drug: Carboplatin · Drug: Paclitaxel · Radiation: Radiation Therapy
400mg bid starting 1 week before radiotherapy and taken through radiotherapy.
Also known as: Celebrex
IV, AUC 2.0, weekly for weeks 1 through 7
Also known as: Paraplatin
IV 30 mg/m2, weekly for weeks 1 through 7
Also known as: Taxol
70.2Gy, at 1.8Gy qd, Monday through Friday
Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.
Particpants experiencing Acute Toxicities \> Grade 3
Time frame: 2 years from radiation therapy
Response as Evaluated by Recurrence of Diseases
Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.
Time frame: 2 years from end of treatment (Radiation therapy)
| Milestone | Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Particpants experiencing Acute Toxicities \> Grade 3
| participants | Acute Toxicity |
|---|---|
| Hematologic | 12 |
| Dermatitis | 7 |
| Mucositis/Dysphagia | 16 |
Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.
| Participants | Recurrence |
|---|---|
| Local Control Only | 6 |
| Local Control and Distant Metastasis | 2 |
| Distant Metastatsis Only | 1 |
| Secondary Primary - Site Unknown | 2 |
| Surgical Salvage | 3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy | — | 12/30 (40%) | 29/30 (96.7%) |
| Event | Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy |
|---|---|
| VomitingGastrointestinal disorders | 3/30 |
| NeutropeniaBlood and lymphatic system disorders | 3/30 |
| Febrile NeutropeniaImmune system disorders | 2/30 |
| StrokeVascular disorders | 1/30 |
| AnemiaBlood and lymphatic system disorders | 1/30 |
| PneumoniaInfections and infestations | 1/30 |
| ThrombosisVascular disorders | 1/30 |
| SyncopeNervous system disorders | 1/30 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/30 |
| Radiation DermatitisSkin and subcutaneous tissue disorders | 1/30 |
| Event | Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy |
|---|---|
| DysphagiaGastrointestinal disorders | 21/30 |
| NeutropeniaBlood and lymphatic system disorders | 10/30 |
| MucositisGastrointestinal disorders | 8/30 |
| Radiation DermatitisSkin and subcutaneous tissue disorders | 5/30 |
| EsophagitisGastrointestinal disorders | 3/30 |
| NauseaGastrointestinal disorders | 3/30 |
| DehydrationMetabolism and nutrition disorders | 3/30 |
| AnemiaBlood and lymphatic system disorders | 2/30 |
| VomitingGastrointestinal disorders | 2/30 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/30 |
| Age, Categorical(Participants) | Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 1 |
| Age Continuous(years) | Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy |
|---|---|
| Mean | 53.83 ± 8.06 |
| Sex: Female, Male(Participants) | Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy |
|---|---|
| Female | 4 |
| Male | 26 |
| Region of Enrollment(participants) | Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy |
|---|---|
| United States | 30 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham