Squamous Cell CarcinomaPhase 1/2NCT00139243
Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
A Phase 1/2 study testing Taxotere, Cisplatin and 5-Fluorouracil in people with Squamous Cell Carcinoma and Carcinoma of Head and/or Neck, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Carcinoma of Head and/or Neck
- What is being tested?
- Taxotere, Cisplatin and 5-Fluorouracil
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 1997to Jan 2006
- Phase
- Phase 1/2
- 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
- Histologic documentation of squamous cell carcinoma of head and neck
- Patients will previously untreated stage III or IV squamous cell carcinoma.
- Patients with locally recurrent disease after surgery.
- Life expectancy of longer than 3 months.
- Kidney function: 1.5 or a 24 hour creatinine clearance of > 30ml/min
- Liver function: SGOT < 1.5 X upper normal limit and alkaline phosphatase of < 2.5 X upper normal limit.
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- WBC greater than or equal to 4,000/mm
- Platelet count greater than or equal to 100,000/mm
- Hemoglobin greater than or equal to 10gm/dl
- Patients of child-bearing age must use effective methods of contraception.
Who cannot join
- Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
- Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
- Pregnant or breast-feeding women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.
Read the detailed description
- Patients will be premedicated at home with dexamethasone and leucovorin.
- On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy.
- During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle.
- At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end. If significant reduction in the size of the tumor is observed, a third and final cycle will be done.
- After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.
- Being tested
- Taxotere, Cisplatin, 5-Fluorouracil, Leucovorin
- Keywords
- squamous cell carcinoma, Taxotere, carcinoma of head/neck, Cisplatin, 5-Fluorouracil, Leucovorin
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxotereDrug
CisplatinDrug
5-FluorouracilDrug
LeucovorinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
Secondary outcomes (2)
To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
to obtain preliminary information about the effectiveness of the drug combination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startOct 1997
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Investigators
- Marshall Posner, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139243
- Sponsor's protocol ID
- 97-130
- Status last verified
- Jun 2008
- First submitted
- 29 Aug 2005
- Last updated
- 4 Jun 2008
- Results posted
- No
Publications
Colevas AD, Norris CM, Tishler RB, Lamb CC, Fried MP, Goguen LA, Gopal HV, Costello R, Read R, Adak S, Posner MR. Phase I/II trial of outpatient docetaxel, cisplatin, 5-fluorouracil, leucovorin (opTPFL) as induction for squamous cell carcinoma of the head and neck (SCCHN). Am J Clin Oncol. 2002 Apr;25(2):153-9. doi: 10.1097/00000421-200204000-00010.
PubMed 11943893Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8. doi: 10.1002/cncr.11063.
PubMed 12518365
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00139243
- Acronym / sponsor ID
- 97-130
- Keywords
- squamous cell carcinoma, Taxotere, carcinoma of head/neck, Cisplatin, 5-Fluorouracil, Leucovorin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Sanofi, Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Study start
- Oct 1997
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 31 Aug 2005 (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 determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.
Detailed description
- Patients will be premedicated at home with dexamethasone and leucovorin.
- On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy.
- During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle.
- At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end. If significant reduction in the size of the tumor is observed, a third and final cycle will be done.
- After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.
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 (10 listed)
- Histologic documentation of squamous cell carcinoma of head and neck
- Patients will previously untreated stage III or IV squamous cell carcinoma.
- Patients with locally recurrent disease after surgery.
- Life expectancy of longer than 3 months.
- Kidney function: 1.5 or a 24 hour creatinine clearance of > 30ml/min
Key exclusion criteria (3 listed)
- Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
- Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Taxotere | Drug | – |
| Cisplatin | Drug | – |
| 5-Fluorouracil | Drug | – |
| Leucovorin | Drug | – |
Primary outcome
To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
2 secondary outcomes
To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
to obtain preliminary information about the effectiveness of the drug combination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
- Background: PubMed 11943893Colevas AD, Norris CM, Tishler RB, Lamb CC, Fried MP, Goguen LA, Gopal HV, Costello R, Read R, Adak S, Posner MR. Phase I/II trial of outpatient docetaxel, cisplatin, 5-fluorouracil, leucovorin (opTPFL) as induction for squamous cell carcinoma of the head and neck (SCCHN). Am J Clin Oncol. 2002 Apr;25(2):153-9. doi: 10.1097/00000421-200204000-00010.
- Background: PubMed 12518365Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8. doi: 10.1002/cncr.11063.
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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.
Marshall Posner, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Taxotere, Cisplatin and 5-Fluorouracil in people with Squamous Cell Carcinoma and Carcinoma of Head and/or Neck, run by Dana-Farber Cancer Institute 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 10 inclusion and 3 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: finished, as of the sponsor's last update on 4 Jun 2008. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00139243, which also lists 2 linked publications.
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 4 Jun 2008.