Head and Neck CancerPhase 1NCT00080028
Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
A Phase 1 study testing Motexafin Gadolinium Injection in people with Head and Neck Cancer and Oropharynx Cancer, run by Pharmacyclics LLC. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oropharynx Cancer, Larynx Cancer
- What is being tested?
- Motexafin Gadolinium Injection
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Each patient must sign a study-specific informed consent form
- Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI
- Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin
- Karnofsky Performance Status score of at least 60%
- Primary tumor at least 4 cm in diameter
Who cannot join
- Laboratory Values of:
- Serum creatinine > 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min
- Serum total bilirubin > 1.5 times the upper limit of normal
- ALT (formerly SGPT) > 1.5 times the upper limit of normal
- Alkaline phosphatase > 1.5 times the upper limit of normal
- Absolute neutrophil count (ANC) < 1500/L
Show all 13Show fewer
- Platelet count < 100,000/L
- 3+ or greater proteinuria on urinalysis
- and
- Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx
- Distant metastases
- Prior history of cancer at any site treated with radiotherapy and/or chemotherapy
- History of SCCHN diagnosed within 5 years of current diagnosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina
University of Texas, San Antonio Health Science Center
San Antonio, Texas
About this study
Official title: Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.
- Being tested
- Motexafin Gadolinium Injection
- Keywords
- Head and Neck Cancer, SCCHN, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer, Soft palate Cancer, Tonsil Cancer, Base of tongue Cancer, Supraglottic Cancer, Glottic Cancer, Pyriform Sinus Cancer, Pharyngeal wall Cancer, Throat cancer
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Hypopharyngeal Neoplasms, Tonsillar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motexafin Gadolinium InjectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080028
- Sponsor's protocol ID
- PCYC-0210
- Status last verified
- May 2007
- First submitted
- 22 Mar 2004
- Last updated
- 8 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00080028
- Acronym / sponsor ID
- PCYC-0210
- Keywords
- Head and Neck Cancer, SCCHN, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer, Soft palate Cancer, Tonsil Cancer, Base of tongue Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- First posted
- 23 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Each patient must sign a study-specific informed consent form
- Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI
- Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin
- Karnofsky Performance Status score of at least 60%
Key exclusion criteria (13 listed)
- Serum creatinine > 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min
- Serum total bilirubin > 1.5 times the upper limit of normal
- ALT (formerly SGPT) > 1.5 times the upper limit of normal
- Alkaline phosphatase > 1.5 times the upper limit of normal
- Absolute neutrophil count (ANC) < 1500/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motexafin Gadolinium Injection | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motexafin Gadolinium Injection in people with Head and Neck Cancer and Oropharynx Cancer, run by Pharmacyclics LLC. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2007.