NCT00028028

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2001

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

4.9 years

First QC Date

December 7, 2001

Last Update Submit

February 27, 2013

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    A log-rank test will compare the PFS curves of both arms.

    Time to death or relapse, assessed up to 6 years

Secondary Outcomes (1)

  • Toxicity rate graded according to NCI CTC version 2.0

    Up to 6 years

Study Arms (2)

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.

Drug: temsirolimusOther: pharmacological studyOther: laboratory biomarker analysis

Arm II

EXPERIMENTAL

Patients receive high-dose CCI-779 as in arm I.

Drug: temsirolimusOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

temsirolimusDRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel
Arm IArm II
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm IArm II
laboratory biomarker analysisOTHER

Correlative studies

Arm IArm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

temsirolimusSirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Kishan Pandya

    Eastern Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2001

First Posted

January 27, 2003

Study Start

February 1, 2002

Primary Completion

January 1, 2007

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)