Lung CancerPhase 1NCT00356941
Oxaliplatin, Docetaxel, and Radiation Therapy in Treating Patients With Unresectable Stage II/III or Recurrent NSCLC
A Phase 1 study testing docetaxel, oxaliplatin and radiation therapy in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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?
- docetaxel, oxaliplatin and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to May 2007
- 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
- Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
- Medically inoperable or unresectable stage II, IIIA, or IIIB disease
- Post-resection intrathoracic tumor recurrence
- Measurable disease by computed tomography(CT) scan
- No evidence of small cell histology
- No significant pleural effusion on chest x-ray or malignant pleural effusion on cytology
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- No metastatic disease
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
- Absolute granulocyte count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL
- Bilirubin ≤ 1.5 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT) ≤ 1.5 times upper limit of normal (unless abnormality is caused by documented benign disease)
- Creatinine ≤ 1.5 mg/dL
- Weight loss ≤ 10% within the past 3 months
- Forced expiratory volume (FEV) 1 ≥ 1,000 cc
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Who cannot join
- Synchronous (except for nonmelanomatous skin cancer) or prior invasive malignancy, unless disease free for > 3 years
- Myocardial infarction within the past 6 months
- Symptomatic heart disease, including any of the following:
- Angina
- Congestive heart failure
- Uncontrolled arrhythmia
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- Active infection or fever ≥ 38.5°C within the past 3 days
- Known hypersensitivity to any of the components of oxaliplatin or docetaxel
- Prior thoracic or neck radiotherapy
- Prior docetaxel or oxaliplatin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and docetaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when given together with docetaxel and radiation therapy in treating patients with unresectable stage II or stage III or recurrent non-small cell lung cancer .
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of oxaliplatin when given with docetaxel and thoracic radiotherapy in patients with unresectable stage II, IIIA, or IIIB or recurrent non-small cell lung cancer.
Secondary
- Determine the dose-limiting toxicities of this regimen in these patients.
- Determine the objective tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of oxaliplatin.
- Induction therapy: Patients undergo radiotherapy once a day on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Patients also receive docetaxel intravenous (IV) over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and oxaliplatin IV over 2-4 hours on days 2, 9, 16, 23, 30, 37, and 44. Patients with stable or responding disease proceed to consolidation therapy.
Cohorts of 6 patients receive escalating doses of oxaliplatin during induction therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.
- Consolidation therapy: Beginning 3 weeks after the completion of induction therapy, patients receive consolidation therapy comprising docetaxel IV over 1 hour immediately followed by oxaliplatin IV over 2-4 hours on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months for up to 2 years.
- Conditions
- Lung Cancer
- Being tested
- docetaxel, oxaliplatin, radiation therapy
- Keywords
- recurrent non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called Taxotere
60 mg/m2 on day 1 of each week during radiation therapy
oxaliplatinDrug
Also called Eloxatin
Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy
radiation therapyProcedure or surgery
Also called radiotherapy
2 Gy Days 1-5 each week, total dose of 70Gy
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation Treated Patients | Experimental | Patients receiving Docetaxel, Oxaliplatin and radiotherapy. Receives: Drug: docetaxel; Drug: oxaliplatin; Procedure: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy
Measured: Within 90 days of radiotherapy
Secondary outcomes (2)
Dose-limiting toxicities
Measured: Within 90 days of radiotherapy
Objective tumor response
Measured: Every 3 months up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: Withdrawn due to lack of accrual
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 Masonic Cancer Center, University of MinnesotaThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- L. Chinsoo Cho, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356941
- Sponsor's protocol ID
- 2005LS073
- Other IDs
- UMN-0511M77529, UMN-OX-04-007
- Status last verified
- Nov 2017
- First submitted
- 26 Jul 2006
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00356941
- Acronym / sponsor ID
- 2005LS073
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn due to lack of accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 27 Jul 2006 (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, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and docetaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when given together with docetaxel and radiation therapy in treating patients with unresectable stage II or stage III or recurrent non-small cell lung cancer .
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of oxaliplatin when given with docetaxel and thoracic radiotherapy in patients with unresectable stage II, IIIA, or IIIB or recurrent non-small cell lung cancer.
Secondary
- Determine the dose-limiting toxicities of this regimen in these patients.
- Determine the objective tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of oxaliplatin.
- Induction therapy: Patients undergo radiotherapy once a day on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Patients also receive docetaxel intravenous (IV) over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and oxaliplatin IV over 2-4 hours on days 2, 9, 16, 23, 30, 37, and 44. Patients with stable or responding disease proceed to consolidation therapy.
Cohorts of 6 patients receive escalating doses of oxaliplatin during induction therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.
- Consolidation therapy: Beginning 3 weeks after the completion of induction therapy, patients receive consolidation therapy comprising docetaxel IV over 1 hour immediately followed by oxaliplatin IV over 2-4 hours on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation Treated Patients | Experimental | Drug: docetaxel, Drug: oxaliplatin, Procedure: radiation therapyPatients receiving Docetaxel, Oxaliplatin and radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
- Measurable disease by computed tomography(CT) scan
- No evidence of small cell histology
- No significant pleural effusion on chest x-ray or malignant pleural effusion on cytology
- No metastatic disease
Key exclusion criteria (10 listed)
- Synchronous (except for nonmelanomatous skin cancer) or prior invasive malignancy, unless disease free for > 3 years
- Myocardial infarction within the past 6 months
- Symptomatic heart disease, including any of the following:
- Active infection or fever ≥ 38.5°C within the past 3 days
- Known hypersensitivity to any of the components of oxaliplatin or docetaxel
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 |
|---|---|---|
| docetaxelAlso: Taxotere60 mg/m2 on day 1 of each week during radiation therapy | Drug | Chemoradiation Treated Patients |
| oxaliplatinAlso: EloxatinEscalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy | Drug | Chemoradiation Treated Patients |
| radiation therapyAlso: radiotherapy2 Gy Days 1-5 each week, total dose of 70Gy | Procedure or surgery | Chemoradiation Treated Patients |
Primary outcome
Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy
Time frame: Within 90 days of radiotherapy
2 secondary outcomes
Dose-limiting toxicities
Time frame: Within 90 days of radiotherapy
Objective tumor response
Time frame: Every 3 months up to 24 months
Results and safety
The study was stopped early (reason given: Withdrawn due to lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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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.
L. Chinsoo Cho, MD study chair
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing docetaxel, oxaliplatin and radiation therapy in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota 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?
The sponsor lists 19 inclusion and 10 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 29 Nov 2017. 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 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 (reason given: Withdrawn due to lack of accrual). 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.
What does the primary outcome measure?
Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy (time frame: Within 90 days of radiotherapy). It is what the study was designed to measure, not a finding.
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 29 Nov 2017.