An interventional study of Cisplatin and cetuximab in Head and Neck Squamous Cell Cancer, sponsored by Georgetown University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-02.
Sponsored by Georgetown University · Not applicable, Interventional, and Treatment
This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery.
The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with radiation therapy. In this study the investigators will test whether genetic differences between patients can be used to pick which of these two drugs a patient should receive. All patients will have a blood sample drawn that will be tested for genetic differences. If patients have genetic differences that correlate with a better outcome from cisplatin they will receive cisplatin with radiation. If patients have genetic differences that do not correlate with a better outcome from cisplatin they will receive cetuximab with their radiation therapy.
Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as primary therapy with curative intent will be enrolled. Patients will be genotyped for germline variations at four SNP loci in three genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin (Arm A). Patients with 2 or fewer variants will receive cetuximab (Arm B).
The hypothesis of the study is that prospectively testing patients for variations in DNA repair enzymes to determine whether to use cisplatin or cetuximab in locally advanced head and neck squamous cell cancer is feasible.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 2 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cisplatin
Drug: Cisplatin · Radiation: Radiation
cetuximab
Drug: cetuximab · Radiation: Radiation
Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy
Also known as: Cispaltin, Platinum
Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.
Also known as: Erbitux
daily radiation for 7 weeks
Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician
Feasibility is defined as follows: - Patients' genetic test results are returned to the treating physician within 3 days
Time frame: 20 months
| Milestone | Cisplatin | Cetuximab |
|---|---|---|
| Started | 1 | 1 |
| Completed | 0 | 1 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
Feasibility is defined as follows: - Patients' genetic test results are returned to the treating physician within 3 days
| days | Cisplatin | Cetuximab |
|---|---|---|
| Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician | 3 (3 to 3) | 3 (3 to 3) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cisplatin | — | 0/1 (0%) | 0/1 (0%) |
| Cetuximab | — | 0/1 (0%) | 0/1 (0%) |
male, caucasian, adult over 18
| Age, Categorical(Participants) | Cisplatin | Cetuximab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Cisplatin | Cetuximab | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Cisplatin | Cetuximab | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cisplatin | Cetuximab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cisplatin | Cetuximab | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
This study is terminated, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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