Limited Stage Small Cell Lung CancerPhase 2NCT00066742
Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer
A Phase 2 study testing tirapazamine, cisplatin and etoposide in people with Limited Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited Stage Small Cell Lung Cancer
- What is being tested?
- tirapazamine, cisplatin and etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically or cytologically confirmed diagnosis of limited small cell lung cancer; diagnosis on the basis of sputum cytology is acceptable if confirmation by an independent pathologic review at the institution is documented
- Patients must have measurable OR non-measurable disease documented by CT, MRI or X-ray; any scan abnormalities, which may otherwise represent metastatic disease, should be confirmed benign by appropriate tests and documented on the baseline tumor assessment form (form #848); if an abnormality is present at baseline, it is assumed to be disease involvement unless proven otherwise; disease must be assessed within 28 days prior to registration for measurable disease and 42 days prior to registration for non-measurable disease; NOTE: The use of PET scans for tumor imaging is not allowed
- Patients with any brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate CNS disease within 42 days prior to registration
- Patients with malignant pericardial effusions OR malignant pleural effusions are ineligible; these are defined as either cytologically positive effusions OR exudative effusions not attributable to other etiologies; patients with effusions too small to tap are eligible
- Patients must have a measured or calculated creatinine clearance >= 50 cc/min obtained within 28 days prior to registration; serum creatinine is only necessary if calculated CrCl is used; if calculated CrCl is used, serum creatinine must be < 1.5 mg/dl
- ANC >= 1,500/ul obtained within 28 days prior to registration
Show all 22Show fewer
- Platelet count >= 100,000/ul obtained within 28 days prior to registration
- Serum bilirubin =< 1.5 x the institutional upper limit of normal within 28 days prior to registration
- SGOT or SGPT =< 2 x the institutional upper limit of normal within 28 days prior to registration
- All patients must have a Zubrod performance status of 0-1
- Patients must not have received previous chemotherapy or biologic therapy for small cell lung cancer; patients must not have received prior thoracic or neck radiation for any reason
- At least two weeks must have elapsed since surgery (thoracic or other major surgeries) and patients must have recovered from all associated toxicities; measurable or non-measurable disease must be present outside the area of surgical resection
- Patients with significant clinical hearing loss must be willing to accept the potential for worsening of symptoms
- Patients must not have >= grade 1 symptomatic neuropathy-sensory (NCI Common Terminology Criteria for Adverse Events version 3.0)
- Patients must have a pre-registration FEV1 and DLCO obtained within 28 days prior to registration
- Institutions must have received IRB approval of S9925 (the Lung Cancer Specimen Repository); patients must be offered participation in S9925; with the patient's consent, plasma, serum and tissue will be submitted for testing via S9925; patients must be registered separately to S9925 to receive credit for specimen submission
- The radiation oncology facility must be willing to deliver 3D conformal radiation; if the radiation therapy is to be done at a different institution, then the institution name and ID must be provided; the radiation therapy facility must be SWOG-approved; NOTE: The radiation oncology facility must have successfully completed the benchmark material from the Quality Assurance Review Center (QARC) or be willing to complete the benchmark material prior to submission of the final radiation forms due within 30 days of completing radiation therapy
- No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for at least 5 years
- If day 28 or 42 falls on a weekend of holiday, the limit may be extended to the next working day; in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines
- Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents; women of reproductive potential must have agreed to use an effective contraceptive method
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- At the times of patient registration, the treating institution's name and ID number must be provided to the Data Operation Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the database
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Oncology Group (SWOG) Research Base
San Antonio, Texas, 78245
About this study
Official title: A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in 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. Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess overall survival in patients with limited stage small cell lung cancer (SCLC) treated with induction tirapazamine combined with cisplatin, etoposide and high dose thoracic radiotherapy followed by consolidative cisplatin and etoposide.
II. To assess time to treatment failure calculated from initiation of step 1, response (confirmed plus unconfirmed, complete plus partial during induction in the subset of patients with measurable disease) and toxicity in this patient population treated with this regimen.
III. To investigate in an exploratory manner the association of baseline PAI-1, VEGF, OPN and NDRG1 plasma markers with patient response and survival.
OUTLINE: This is a multicenter study.
CHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks.
CONSOLIDATION CHEMOTHERAPY: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17 months.
- Conditions
- Limited Stage Small Cell Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirapazamineDrug
Also called SR 4233, Tirazone, WIN 59075
Given IV
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
etoposideDrug
Also called EPEG, VP-16, VP-16-213
Given IV
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (tirapazamine, cisplatin, etoposide) | Experimental | CHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks.
CONSOLIDATION CHEMOTHERAPY: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24.
Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: tirapazamine; Drug: cisplatin; Drug: etoposide; Radiation: radiation therapy; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.
Measured: Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.
Secondary outcomes (2)
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.
A complete response (CR) was defined as a complete disappearance of all disease with no new lesions. A partial response (PR) was defined as at least a 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. Both CR and PR had to be confirmed by a second determination at least 4 weeks apart. All disease had to be assessed using same method as baseline. Only patients with measurable disease at baseline were included in this analysis.
Measured: After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.
Progression-Free Survival
Progression was defined as a >= 20% increase in the sum of longest diameters of measurable lesions over the smallest sum observed or unequivocal progression of non-measurable disease or the appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring discontinuation of treatment. Progression-free survival was defined as the time from the date of enrollment until the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.
Measured: At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startSep 2003
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Limited Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Quynh-Thu Le, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066742
- Sponsor's protocol ID
- NCI-2012-03042
- Other IDs
- NCI-2012-03042, U10CA032102, S0222, S0222
- Status last verified
- Dec 2012
- First submitted
- 6 Aug 2003
- Last updated
- 15 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00066742
- Acronym / sponsor ID
- NCI-2012-03042
- Conditions
- Limited Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Aug 2003 (estimated)
- Results
- Posted 19 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in 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. Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To assess overall survival in patients with limited stage small cell lung cancer (SCLC) treated with induction tirapazamine combined with cisplatin, etoposide and high dose thoracic radiotherapy followed by consolidative cisplatin and etoposide.
II. To assess time to treatment failure calculated from initiation of step 1, response (confirmed plus unconfirmed, complete plus partial during induction in the subset of patients with measurable disease) and toxicity in this patient population treated with this regimen.
III. To investigate in an exploratory manner the association of baseline PAI-1, VEGF, OPN and NDRG1 plasma markers with patient response and survival.
OUTLINE: This is a multicenter study.
CHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks.
CONSOLIDATION CHEMOTHERAPY: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (tirapazamine, cisplatin, etoposide) | Experimental | Drug: tirapazamine, Drug: cisplatin, Drug: etoposide, Radiation: radiation therapy, Other: laboratory biomarker analysisCHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks. CONSOLIDATION CHEMOTHERAPY: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must have histologically or cytologically confirmed diagnosis of limited small cell lung cancer; diagnosis on the basis of sputum cytology is acceptable if confirmation by an independent pathologic review at the institution is documented
- Patients must have measurable OR non-measurable disease documented by CT, MRI or X-ray; any scan abnormalities, which may otherwise represent metastatic disease, should be confirmed benign by appropriate tests and documented on the baseline tumor assessment form (form #848); if an abnormality is present at baseline, it is assumed to be disease involvement unless proven otherwise; disease must be assessed within 28 days prior to registration for measurable disease and 42 days prior to registration for non-measurable disease; NOTE: The use of PET scans for tumor imaging is not allowed
- Patients with any brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate CNS disease within 42 days prior to registration
- Patients with malignant pericardial effusions OR malignant pleural effusions are ineligible; these are defined as either cytologically positive effusions OR exudative effusions not attributable to other etiologies; patients with effusions too small to tap are eligible
- Patients must have a measured or calculated creatinine clearance >= 50 cc/min obtained within 28 days prior to registration; serum creatinine is only necessary if calculated CrCl is used; if calculated CrCl is used, serum creatinine must be < 1.5 mg/dl
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| tirapazamineAlso: SR 4233, Tirazone, WIN 59075Given IV | Drug | Treatment (tirapazamine, cisplatin, etoposide) |
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Treatment (tirapazamine, cisplatin, etoposide) |
| etoposideAlso: EPEG, VP-16, VP-16-213Given IV | Drug | Treatment (tirapazamine, cisplatin, etoposide) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy | Radiation | Treatment (tirapazamine, cisplatin, etoposide) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (tirapazamine, cisplatin, etoposide) |
Primary outcome
Overall Survival
Time frame: Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.
Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.
2 secondary outcomes
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.
Time frame: After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.
Progression-Free Survival
Time frame: At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Quynh-Thu Le principal investigator
SWOG Cancer Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tirapazamine, cisplatin and etoposide in people with Limited Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) 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 22 inclusion and 0 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 15 May 2014. 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 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?
Yes. Results are posted in the registry (first posted 19 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.). 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 15 May 2014.