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CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00028028
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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

Condition or disease Intervention/treatment Phase
Extensive Stage Small Cell Lung Cancer Drug: temsirolimus Other: pharmacological study Other: laboratory biomarker analysis Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2002
Actual Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies

Experimental: Arm II
Patients receive high-dose CCI-779 as in arm I.
Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Toxicity rate graded according to NCI CTC version 2.0 [ Time Frame: Up to 6 years ]
    The difference in the true toxicity rates of the two arms will be detected using Fisher's exact test.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028028


Locations
United States, Massachusetts
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kishan Pandya Eastern Cooperative Oncology Group

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028028     History of Changes
Other Study ID Numbers: NCI-2012-03146
E1500
U10CA021115 ( U.S. NIH Grant/Contract )
CDR0000069118 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents