Lung CancerPhase 3NCT00055887
Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
A Phase 3 study testing carboplatin, cisplatin and efaproxiral in people with Lung Cancer, run by Spectrum Pharmaceuticals, Inc at 22 sites in 4 countries.
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. Drugs such as efaproxiral may make the 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
- Lung Cancer
- What is being tested?
- carboplatin, cisplatin and efaproxiral
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Nov 2002to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer of 1 of the following subtypes:
- Adenocarcinoma
- Squamous cell carcinoma
- Large cell carcinoma
- Poorly differentiated carcinoma
- Stage IIIA or IIIB
- T1 or T2, N2
- T3, N1 or N2
- T4, any N
- Any T, N3
- Histological or cytological confirmation of at least 1 positive lymph node required if the largest mediastinal node that is the basis of stage III disease is less than 2.0 cm in diameter
- Clinically or radiologically measurable disease of at least 2.0 cm
- Partially resected stage IIIB disease allowed provided a measurable lesion remains
- No pleural effusion that is bloody, cytologically positive, or re-accumulated after thoracentesis
- No metastatic disease by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin at least 10 g/dL
- WBC at least 3,000/mm^3
- Absolute granulocyte count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No clinically active congestive heart failure
- No unstable angina
- No severe arrhythmia by ECG
Pulmonary
- FVC and FEV_1 at least 50% of normal
- Resting oxygen saturation by pulse oximetry (SpO_2) at least 90% on room air
- Exercise SpO_2 at least 90% on room air
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception during and for 30 days after study therapy
- Male patients must use effective contraception during and for 90 days after study therapy
- No loss of more than 10% of body weight within the past 3 months
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No significantly altered mental status or dementia that would preclude giving informed consent
- No active infection
- No other serious underlying medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 28 days since prior biologic therapy
- No concurrent colony-stimulating factors (randomized phase only)
- No biologic therapy during and for 1 month after study therapy
- No immune response modifiers during and for 1 month after study therapy
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- No hormonal therapy during and for 1 month after study therapy
Radiotherapy
- No prior thoracic radiotherapy
Surgery
- See Disease Characteristics
- No prior total surgical resection
Other
- More than 28 days since prior investigational drugs or devices
- No prior efaproxiral
- No other cytotoxic therapy during and for 1 month after study therapy
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Canada9 sites
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Hopital Notre- Dame du CHUM
Montreal, Quebec, H2L 4M1
McGill University
Montreal, Quebec, H2W 1S6
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6
United States8 sites
St. Agnes Cancer Center
Baltimore, Maryland, 21229
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814
Providence Everett Medical Center - Pacific Campus
Everett, Washington, 98206
Cancer Center at Lexington Clinic
Lexington, Kentucky, 40504
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Willis - Knighton Cancer Center
Shreveport, Louisiana, 71103-3951
Schiffler Cancer Center
Wheeling, West Virginia, 26003
Israel4 sites
Soroka University Medical Center
Beersheba, 84101
Rambam Medical Center
Haifa, 31096
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) 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. Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with induction chemotherapy followed by radiotherapy with or without efaproxiral.
- Compare time to progression, response rate, and pattern of failure of patients treated with these regimens.
- Determine the safety of efaproxiral in these patients.
- Determine the pharmacokinetics of efaproxiral in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to chemotherapy regimen, Karnofsky performance status (70-80% vs 90-100%), and disease stage (IIIA vs IIIB).
- Induction therapy phase: Patients receive 1 of the following induction chemotherapy regimens:
- Paclitaxel and carboplatin: Patients receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for a total of 2 courses.
- Cisplatin and gemcitabine: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
- Cisplatin and vinorelbine: Patients receive cisplatin IV on day 1 and vinorelbine IV on days 1, 8, and either 15 or 22. Treatment repeats every 28 days for a total of 2 courses.
- Randomized phase: Within 42 days after completion of chemotherapy, patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive efaproxiral IV over 30-45 minutes with supplemental oxygen and then undergo concurrent radiotherapy 5 days a week for 7 weeks.
- Arm II: Patients receive supplemental oxygen and undergo radiotherapy as in arm I.
Quality of life is assessed at baseline, on days 1 and 16 of radiotherapy, monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 659 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, cisplatin, efaproxiral, gemcitabine hydrochloride, paclitaxel
- Keywords
- stage IIIB non-small cell lung cancer, stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
cisplatinDrug
efaproxiralDrug
paclitaxelDrug
vinorelbine ditartrateDrug
radiation therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startNov 2002
Why it stopped: Study never started. No patients were enrolled.
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.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hak Choy, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055887
- Sponsor's protocol ID
- CDR0000271438
- Other IDs
- ALLOS-RSR13RT-013ELITE
- Status last verified
- May 2013
- First submitted
- 6 Mar 2003
- Last updated
- 10 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00055887
- Acronym / sponsor ID
- CDR0000271438
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started. No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- First posted
- 7 Mar 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. Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with induction chemotherapy followed by radiotherapy with or without efaproxiral.
- Compare time to progression, response rate, and pattern of failure of patients treated with these regimens.
- Determine the safety of efaproxiral in these patients.
- Determine the pharmacokinetics of efaproxiral in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to chemotherapy regimen, Karnofsky performance status (70-80% vs 90-100%), and disease stage (IIIA vs IIIB).
- Induction therapy phase: Patients receive 1 of the following induction chemotherapy regimens:
- Paclitaxel and carboplatin: Patients receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for a total of 2 courses.
- Cisplatin and gemcitabine: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
- Cisplatin and vinorelbine: Patients receive cisplatin IV on day 1 and vinorelbine IV on days 1, 8, and either 15 or 22. Treatment repeats every 28 days for a total of 2 courses.
- Randomized phase: Within 42 days after completion of chemotherapy, patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive efaproxiral IV over 30-45 minutes with supplemental oxygen and then undergo concurrent radiotherapy 5 days a week for 7 weeks.
- Arm II: Patients receive supplemental oxygen and undergo radiotherapy as in arm I.
Quality of life is assessed at baseline, on days 1 and 16 of radiotherapy, monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 659 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
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 |
|---|---|---|
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| efaproxiral | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| paclitaxel | Drug | – |
| vinorelbine ditartrate | Drug | – |
| radiation therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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.
Hak Choy, MD study chair
Simmons Cancer Center
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin, cisplatin and efaproxiral in people with Lung Cancer, run by Spectrum Pharmaceuticals, Inc at 22 sites in 4 countries.
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: withdrawn, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada, United States, Israel, Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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 10 May 2013.