Extensive Stage Small Cell Lung CancerPhase 2NCT00028028
CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing temsirolimus, pharmacological study and laboratory biomarker analysis in people with Extensive Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Randomized phase II trial to compare the effectiveness of different doses of CCI-779 in treating patients who have extensive-stage small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- temsirolimus, pharmacological study and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Jan 2007
- 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
Who may be able to join
- Patients must have histologically-confirmed small cell carcinoma of the lung or unequivocally positive cytological evidence (sputum [at least 2] or aspirate biopsy), with extensive disease (disease beyond the hemithorax and adjacent nodes, supraclavicular node involvement or pleural effusion with positive cytology), who have required induction chemotherapy, who have responding or stable disease, and who meet the following criteria:
- Induction chemotherapy including platinum (cisplatin or carboplatin) plus either etoposide (VP-16) or irinotecan (CPT-11)
- A minimum of 3 and a maximum of 6 cycles of induction chemotherapy have been administered
- Recovered from all toxicity related to prior chemotherapy (except alopecia and/or neuropathy)
- No less than 4 and no more than 8 weeks have elapsed between the last treatment of induction chemotherapy and randomization
- No more than 32 weeks have elapsed between the first dose of induction chemotherapy and date of randomization
Show all 25Show fewer
- The patient has responding or stable disease using RECIST criteria since the initiation of systemic chemotherapy (i.e., patients who have exhibited disease progression are NOT ELIGIBLE)
- Patients must be disease-free for >= 5 years if they have had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Baseline measurements/evaluations of disease must be obtained =< 4 weeks prior to randomization
- WBC >= 4000/mm³ or
- ANC >= 1500/mm³
- Platelet count >= 100,000/mm³
- Total bilirubin =< 1.5 mg/dl
- Creatinine =< 1.5 mg/dl
- Patient's cholesterol level must be < 350mg/dl; (note; if non-fasting levels are high repeat in a fasting state)
- Patient's triglycerides must be < 400mg/dl; (note; if non-fasting levels are high repeat in a fasting state)
- ECOG performance status 0, 1, or 2
- Prior radiation to any symptomatic site is permitted so long as the site(s) of measurable disease are NOT irradiated, and radiation is completed at least 4 weeks before randomization
- Patients must not have had prior treatment with biological response modifiers
- Patients with brain metastases are eligible provided they have received treatment, are asymptomatic and are no longer taking corticosteroids; patients who develop brain metastases after completion of induction chemotherapy are ineligible
- Patients must not be on anticonvulsant therapy
- Patients must not have limited disease
- Patients must not become pregnant and must practice adequate contraception; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and continue approximately 12 weeks after the study is completed; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; female patients who are breastfeeding are also excluded from this study
- Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779, or to any of the components of the CCI-779 formulation; patients must also not be allergic to or for medical reasons are unable to receive antihistamines
- Patients must not be immunocompromised, have an active infection or serious intercurrent infection, or have received known immunosuppressive therapies within 3 weeks randomization
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215
About this study
Official title: A Randomized, Phase II ECOG Trial of Two Dose Levels of CCI-779 in Patients With Extensive-Stage Small Cell Lung Cancer Who Have Responding or Stable Disease After Induction Chemotherapy
Randomized phase II trial to compare the effectiveness of different doses of CCI-779 in treating patients who have extensive-stage small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Read the detailed description
PRIMARY OBJECTIVES:
- To study the progression-free survival in patients who receive a lower or a higher dose of CCI-779, a cytostatic agent following cytoreductive chemotherapy in extensive SCLC.
II. To determine the toxicity of two treatment regimens involving a lower or a higher dose of CCI-779.
SECONDARY OBJECTIVES:
- To quantify the effects of CCI-779 treatment on p70S6 phosphorylation in peripheral blood mononuclear cells of patients with small cell lung cancer who are treated with CCI-779.
II. To measure the effects on mTOR activation and signaling of plasma from patients treated with CCI-779.
III. To determine the relationship between CCI-779 dose and its pharmacodynamic parameters.
IV. To correlate the inhibition of p70S6 with indices of patient outcome.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to brain metastases (yes vs no), prior induction chemotherapy regimen (platinum and etoposide vs platinum and irinotecan), and response to prior induction chemotherapy (complete or partial response vs stable disease). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive high-dose CCI-779 as in arm I.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- temsirolimus, pharmacological study, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temsirolimusDrug
Also called CCI-779, cell cycle inhibitor 779, Torisel
Given IV
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: temsirolimus; Other: pharmacological study; Other: laboratory biomarker analysis |
| Arm II | Experimental | Patients receive high-dose CCI-779 as in arm I. Receives: Drug: temsirolimus; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
A log-rank test will compare the PFS curves of both arms.
Measured: Time to death or relapse, assessed up to 6 years
Secondary outcomes (1)
Toxicity rate graded according to NCI CTC version 2.0
The difference in the true toxicity rates of the two arms will be detected using Fisher's exact test.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2002
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kishan Pandya, Principal investigator, Eastern Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028028
- Sponsor's protocol ID
- NCI-2012-03146
- Other IDs
- E1500, U10CA021115, CDR0000069118
- Status last verified
- Feb 2013
- First submitted
- 7 Dec 2001
- Last updated
- 28 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II ECOG Trial of Two Dose Levels of CCI-779 in Patients With Extensive-Stage Small Cell Lung Cancer Who Have Responding or Stable Disease After Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT00028028
- Acronym / sponsor ID
- NCI-2012-03146
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2002
- Primary completion
- Jan 2007 (actual)
- First posted
- 27 Jan 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.
Randomized phase II trial to compare the effectiveness of different doses of CCI-779 in treating patients who have extensive-stage small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed description
PRIMARY OBJECTIVES:
- To study the progression-free survival in patients who receive a lower or a higher dose of CCI-779, a cytostatic agent following cytoreductive chemotherapy in extensive SCLC.
II. To determine the toxicity of two treatment regimens involving a lower or a higher dose of CCI-779.
SECONDARY OBJECTIVES:
- To quantify the effects of CCI-779 treatment on p70S6 phosphorylation in peripheral blood mononuclear cells of patients with small cell lung cancer who are treated with CCI-779.
II. To measure the effects on mTOR activation and signaling of plasma from patients treated with CCI-779.
III. To determine the relationship between CCI-779 dose and its pharmacodynamic parameters.
IV. To correlate the inhibition of p70S6 with indices of patient outcome.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to brain metastases (yes vs no), prior induction chemotherapy regimen (platinum and etoposide vs platinum and irinotecan), and response to prior induction chemotherapy (complete or partial response vs stable disease). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive high-dose CCI-779 as in arm I.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: temsirolimus, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Drug: temsirolimus, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive high-dose CCI-779 as in arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patients must have histologically-confirmed small cell carcinoma of the lung or unequivocally positive cytological evidence (sputum [at least 2] or aspirate biopsy), with extensive disease (disease beyond the hemithorax and adjacent nodes, supraclavicular node involvement or pleural effusion with positive cytology), who have required induction chemotherapy, who have responding or stable disease, and who meet the following criteria:
- Patients must be disease-free for >= 5 years if they have had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Baseline measurements/evaluations of disease must be obtained =< 4 weeks prior to randomization
- WBC >= 4000/mm³ or
- ANC >= 1500/mm³
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 |
|---|---|---|
| temsirolimusAlso: CCI-779, cell cycle inhibitor 779, ToriselGiven IV | Drug | Arm I, Arm II |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I, Arm II |
| laboratory biomarker analysisCorrelative studies | Other | Arm I, Arm II |
Primary outcome
Progression-free survival (PFS)
Time frame: Time to death or relapse, assessed up to 6 years
A log-rank test will compare the PFS curves of both arms.
1 secondary outcome
Toxicity rate graded according to NCI CTC version 2.0
Time frame: Up to 6 years
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 28 Feb 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.
Kishan Pandya principal investigator
Eastern Cooperative Oncology Group
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 temsirolimus, pharmacological study and laboratory biomarker analysis in people with Extensive 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 25 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 28 Feb 2013. 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?
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.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Time to death or relapse, assessed up to 6 years). 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 28 Feb 2013.