Head and Neck CancerPhase 2NCT00021333
Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
A Phase 2 study testing filgrastim, cisplatin and paclitaxel in people with Head and Neck Cancer and Lung Cancer, run by Fox Chase Cancer Center at 18 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer
- What is being tested?
- filgrastim, cisplatin and paclitaxel
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 18 sitesUnited States
- Study dates
- Sep 1999to May 2008
- Phase
- Phase 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
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Previously irradiated, locally recurrent squamous cell carcinoma of the head and neck (SCCHN) or head and neck skin/appendages with no distant metastases New second or subsequent primary SCCHN in a previously irradiated field with no distant metastases Salivary gland malignancy or other non-squamous cell primary head and neck cancer Previously irradiated, locally recurrent carcinoma of the lung No clinical evidence of symptomatic bone or brain metastases requiring radiotherapy No leptomeningeal metastases requiring intrathecal therapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active, uncontrolled congestive heart failure or arrhythmia within the past 6 months Other: No pre-existing neuropathy grade 2 or greater interfering with daily activities No prior allergy to drugs using Cremophor EL No hypersensitivity to E. coli-derived proteins No significant concurrent medical or psychiatric disorder that would preclude study No other condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy Prior or concurrent cumulative radiotherapy dose to spinal cord no greater than 5,000 cGy Surgery: Not specified Other: Concurrent beta-blockers, digitalis derivatives, or calcium-channel blocking agents allowed if cardiac conditions are stable
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
Kimball Medical Center
Lakewood, New Jersey, 08701
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
Central Montgomery Medical Center
Lansdale, Pennsylvania, 19446-1200
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
Community Medical Center
Toms River, New Jersey, 08755
St. Francis Medical Center
Trenton, New Jersey, 08629
Southern Chester County Medical Center
West Grove, Pennsylvania, 19390
About this study
Official title: Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck, And Lung
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer.
Read the detailed description
OBJECTIVES: I. Determine the response rate of patients with locally recurrent carcinoma of the head and neck or lung treated with paclitaxel and cisplatin with concurrent radiotherapy followed by filgrastim (G-CSF). II. Assess the toxicity of this regimen in these patients. III. Determine the time to progression and the sites and pattern of progression in patients treated with this regimen. IV. Determine the median, 1-year, and 2-year survival rates of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer). Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5. Patients undergo radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-13 or until blood counts recover. Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 42-84 patients (14-28 per stratum) will be accrued for this study within 2-4 years.
- Conditions
- Head and Neck Cancer, Lung Cancer
- Being tested
- filgrastim, cisplatin, paclitaxel, radiation therapy
- Keywords
- recurrent non-small cell lung cancer, recurrent small cell lung cancer, recurrent thyroid cancer, recurrent salivary gland cancer, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Thyroid Neoplasms, Salivary Gland Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
cisplatinDrug
paclitaxelDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2004 (estimated)
- Study startSep 1999
- Primary completionApr 2006
- Study completionMay 2008
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.
- More trials run by Fox Chase Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Corey J. Langer, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021333
- Sponsor's protocol ID
- CDR0000068770
- Other IDs
- P30CA006927, FCCC-99025, NCI-G01-1983
- Status last verified
- Apr 2013
- First submitted
- 11 Jul 2001
- Last updated
- 17 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck, And Lung
- ClinicalTrials.gov ID
- NCT00021333
- Acronym / sponsor ID
- CDR0000068770
- Conditions
- Head and Neck Cancer, Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, recurrent small cell lung cancer, recurrent thyroid cancer, recurrent salivary gland cancer, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1999
- Primary completion
- Apr 2006 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Jan 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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer.
Detailed description
OBJECTIVES: I. Determine the response rate of patients with locally recurrent carcinoma of the head and neck or lung treated with paclitaxel and cisplatin with concurrent radiotherapy followed by filgrastim (G-CSF). II. Assess the toxicity of this regimen in these patients. III. Determine the time to progression and the sites and pattern of progression in patients treated with this regimen. IV. Determine the median, 1-year, and 2-year survival rates of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer). Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5. Patients undergo radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-13 or until blood counts recover. Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 42-84 patients (14-28 per stratum) will be accrued for this study within 2-4 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| filgrastim | Biological | – |
| cisplatin | Drug | – |
| paclitaxel | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
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 17 Apr 2013.
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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.
Corey J. Langer, MD study chair
Fox Chase Cancer Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, cisplatin and paclitaxel in people with Head and Neck Cancer and Lung Cancer, run by Fox Chase Cancer Center at 18 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?
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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 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.
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 17 Apr 2013.