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Lung CancerPhase 2NCT00248482

Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

A Phase 2 study testing Cisplatin, Gleevec™ and irinotecan in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Cisplatin, Gleevec™ and irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
Feb 2002to Jan 2008
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC)
  • Extensive stage disease, defined by 1 of the following criteria:
  • Disease extends beyond one hemithorax and regional lymph nodes
  • Cytologically positive pleural effusion
  • Meets 1 of the following criteria:
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the field of any prior radiotherapy
  • Evaluable disease
  • No history of untreated or symptomatic brain or leptomeningeal metastases
  • Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy

PATIENT CHARACTERISTICS:

Performance status

  • SWOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Meets 1 of the following criteria:
  • Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN
  • AP ≤ 5 times ULN AND AST and ALT normal
  • No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 65 mL/min

Cardiovascular

  • No uncontrolled congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction and/or stroke within the past 3 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No peripheral neuropathy ≥ grade 2
  • No symptomatic edema from any etiology
  • No known HIV positivity
  • No other serious medical illness
  • No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
  • No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy for SCLC

Endocrine therapy

  • No concurrent routine systemic corticosteroids

Radiotherapy

  • See Disease Characteristics
  • At least 2 weeks since prior palliative radiotherapy

Surgery

  • More than 2 weeks since prior major surgery

Other

  • No concurrent therapeutic anticoagulation with warfarin
  • Concurrent low molecular weight heparin allowed provided regimen was initiated ≥ 2 weeks prior to study entry
  • No other concurrent participation in another study of an investigational agent

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

Other trials in United States

About this study

Official title: Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back.

PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the 4-month progression-free survival rate in patients with c-kit positive, extensive stage small cell lung cancer treated with maintenance therapy comprising imatinib mesylate after induction therapy comprising irinotecan and cisplatin.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the tolerability of imatinib mesylate maintenance therapy in these patients.
  • Determine the response rate in patients treated with irinotecan and cisplatin.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response (partial or complete) or stable disease proceed to maintenance therapy.
  • Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months in the absence of disease progression or unacceptable toxicity. Some patients may continue to receive therapy for up to 1 year.

After completion of study treatment, patients are followed for 4 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Conditions
Lung Cancer
Being tested
Cisplatin, Gleevec™, irinotecan
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer
Medical subject headings
Lung Neoplasms, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Platinol ®, Platinol®-AQ, CDDP

    Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles

  • Gleevec™Drug

    Also called STI-571, imatinib mesylate

    Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.

  • irinotecanDrug

    Also called Camptosar®, Camptothecin-11, CPT-11

    Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles

Study groups in NCT00248482
Study groupRoleWhat they receive
Irinotecan, Cisplatin & Gleevec™ExperimentalCisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease. Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
Receives: Drug: Cisplatin; Drug: Gleevec™; Drug: irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: at 4 months

Secondary outcomes (3)
  1. Overall survival

    Measured: at least 4 months after discontinuation of treatment

  2. Tolerability of Gleevec maintenance therapy

    Measured: 30 days after completion of study treatment

  3. Response rate as measured by RECIST at

    Measured: Baseline and every 8 weeks during study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2005 (estimated)
  2. Study startFeb 2002
  3. Primary completionApr 2005
  4. Study completionJan 2008

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00248482
Sponsor's protocol ID
CDR0000445222
Other IDs
P30CA022453, WSU-C-2461, WSU-UMCC-2001-066, CST1571B US93
Status last verified
Apr 2013
First submitted
3 Nov 2005
Last updated
29 Apr 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Gleevec™ and irinotecan in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites 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?

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 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 (time frame: at 4 months). 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 29 Apr 2013.

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