Lung CancerPhase 3NCT00028938
Chemotherapy and Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
A Phase 3 study testing epoetin alfa, carboplatin and paclitaxel in people with Lung Cancer, run by Wake Forest University Health Sciences at 1 site 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- epoetin alfa, carboplatin and paclitaxel
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2002to 10 Nov 2002
- Phase
- Phase 3
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Adenocarcinoma (including bronchoalveolar cell)
- Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin 11.0-15 g/dL
- If hemoglobin is 11.0-11.9 g/dL then the following lab values are required:
- Iron greater than 60 mcg/mL
- Transferrin saturation greater than 20%
- Ferritin at least 100 mg/mL
- Iron binding capacity less than 400 mcg/dL
- RBC folate normal
- B12 normal
Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
Renal:
- Creatinine clearance at least 20 mL/min
Cardiovascular:
- No uncontrolled hypertension
Pulmonary:
- FEV1 at least 0.8 L
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to mammalian cell-derived products or human albumin
- No other concurrent or prior malignancy within the past 2 years except non- melanoma skin cancers
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 30 days since prior transfusion
- No prior epoetin alfa or experimental forms of epoetin alfa
Chemotherapy:
- No prior chemotherapy for NSCLC
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for NSCLC
Surgery:
- At least 2 weeks since prior thoracotomy
Other:
- No concurrent therapy for iron, folate, or B12 deficiency
- No other concurrent anti-cancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: A Phase III Randomized Trial Evaluating the Effect of Epoetin Alfa (Procrit) on Local Control in Patients Undergoing Concurrent Chemotherapy and Radiation Therapy for Non-Small Cell Lung Cancer
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. Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without epoetin alfa in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of epoetin alfa in maintaining hemoglobin levels in patients with stage IIIA or IIIB non-small cell lung cancer when treated with chemoradiotherapy.
- Compare the time to local and systemic progression in patients receiving chemoradiotherapy with or without epoetin alfa.
- Compare tumor response rate and overall survival in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life in patients treated with these regimens.
- Compare the number of transfusions in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (90-100% vs 60-80%), weight loss (no more than 5% vs 6-10%), and baseline hemoglobin (women 11.0-12.4 g/dL and men 11.0-13.4 g/dL vs women 12.5-15.0 g/dL and men 13.5-15.0 g/dL). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 7-10 days before the start of chemoradiotherapy, patients receive epoetin alfa subcutaneously once weekly for 8 weeks. Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 7 weeks. Patients undergo radiotherapy 5 days a week for 7 weeks for a total of 33 treatments. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel, carboplatin, and radiotherapy as in arm I. Quality of life is assessed at baseline, at completion of chemoradiotherapy, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 202-232 patients (101-116 per treatment arm) will be accrued for this study within 1.7-2 years.
- Conditions
- Lung Cancer
- Being tested
- epoetin alfa, carboplatin, paclitaxel, radiation therapy
- Keywords
- squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaBiological
carboplatinDrug
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 posted1 Jul 2003 (estimated)
- Study start1 Jan 2002
- Primary completion10 Nov 2002
- Study completion10 Nov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arthur William Blackstock, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028938
- Sponsor's protocol ID
- REBACDR0000069148
- Other IDs
- CCCWFU-62299, CCCWFU-BG01-193, NCI-P01-0200
- Status last verified
- Sep 2021
- First submitted
- 4 Jan 2002
- Last updated
- 9 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial Evaluating the Effect of Epoetin Alfa (Procrit) on Local Control in Patients Undergoing Concurrent Chemotherapy and Radiation Therapy for Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00028938
- Acronym / sponsor ID
- REBACDR0000069148
- Conditions
- Lung Cancer
- Keywords
- squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 10 Nov 2002 (actual)
- Study completion
- 10 Nov 2002 (actual)
- First posted
- 1 Jul 2003 (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. Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without epoetin alfa in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of epoetin alfa in maintaining hemoglobin levels in patients with stage IIIA or IIIB non-small cell lung cancer when treated with chemoradiotherapy.
- Compare the time to local and systemic progression in patients receiving chemoradiotherapy with or without epoetin alfa.
- Compare tumor response rate and overall survival in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life in patients treated with these regimens.
- Compare the number of transfusions in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (90-100% vs 60-80%), weight loss (no more than 5% vs 6-10%), and baseline hemoglobin (women 11.0-12.4 g/dL and men 11.0-13.4 g/dL vs women 12.5-15.0 g/dL and men 13.5-15.0 g/dL). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 7-10 days before the start of chemoradiotherapy, patients receive epoetin alfa subcutaneously once weekly for 8 weeks. Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 7 weeks. Patients undergo radiotherapy 5 days a week for 7 weeks for a total of 33 treatments. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel, carboplatin, and radiotherapy as in arm I. Quality of life is assessed at baseline, at completion of chemoradiotherapy, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 202-232 patients (101-116 per treatment arm) will be accrued for this study within 1.7-2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| epoetin alfa | Biological | – |
| carboplatin | 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 9 Sep 2021.
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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.
Arthur William Blackstock, MD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa, carboplatin and paclitaxel in people with Lung Cancer, run by Wake Forest University Health Sciences at 1 site 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 9 Sep 2021.