Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028028
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2001-12-07
Brief Title:
CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVES
I 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
I 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
I 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
I 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E1500 | None | None | None |
| U10CA021115 | NIH | None | None |
| CDR0000069118 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |