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Lung CancerPhase 2NCT00281827

Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer

A Phase 2 study testing carboplatin, gemcitabine hydrochloride and thalidomide in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. 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?
carboplatin, gemcitabine hydrochloride and thalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
3 sitesUnited States
Study dates
May 2002to Jul 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Large cell undifferentiated carcinoma
  • Stage II or IIIA disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan
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  • No tumor involving the superior sulcus (e.g., Pancoast tumor)
  • Karnofsky performance status 70-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2 mg/dL
  • Bilirubin < 2 mg/dL
  • Aspartate aminotransferase (AST) < 3 times upper limit of normal

Who cannot join

  • Pregnant or nursing
  • No nursing during and for ≥ 4 weeks after completion of study treatment
  • Positive pregnancy test
  • Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
  • Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
  • Blood, sperm, or ova donation during study treatment
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  • Post obstructive pneumonia
  • Other serious infection or medical illness that would preclude study participation
  • Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years
  • Less than 5 years since prior resection of lung disease
  • Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
  • Other concurrent chemotherapy or radiotherapy
  • Concurrent hormonal therapy or immunotherapy
  • Other concurrent anticancer therapy
  • Other concurrent investigational agents
  • Concurrent participation in another clinical study

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

Other trials in United States

About this study

Official title: Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the complete and partial response rates in patients with stage II or IIIA non-small cell lung cancer treated with neoadjuvant carboplatin, gemcitabine hydrochloride, and thalidomide.

Secondary

  • Determine, preliminarily, the mechanism of action and activity of thalidomide against lung cancer.
  • Determine the 1-year and 2-year survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the operative mortality of patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive carboplatin intravenously (IV) over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after the completion of chemotherapy, patients with resectable tumors undergo surgical resection.

After completion of study treatment, patients are followed every 3 months for 2 years.

Conditions
Lung Cancer
Keywords
adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • carboplatinDrug

    Also called PARAPLATIN

    Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)

  • gemcitabine hydrochlorideDrug

    Also called Gemzar

    Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.

  • thalidomideDrug

    Also called Thalidomid

    Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.

  • conventional surgeryProcedure or surgery

    Also called Surgery, Resection

    Resection - between 2 and 6 weeks following last dose of chemotherapy.

Study groups in NCT00281827
Study groupRoleWhat they receive
Treatment ArmExperimentalChemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.
Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: thalidomide; Procedure: conventional surgery

What is being measured

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

  1. Number of Patients Reporting Clinical Response

    Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.

    Measured: At end of 3 -21 day cycles of treatment

Secondary outcomes (5)

  1. Number of Patients Disease-free at 1 Year

    Calculated from date of enrollment to date of recurrence or death, whichever came first

    Measured: 1 year

  2. Number of Patients Disease-free at 2 Years

    Calculated from date of enrollment to date of recurrence or death, whichever came first

    Measured: 2 Years

  3. Number of Patients Alive at 1 Year (Survival)

    Participants who were alive at one year from date of enrollment .

    Measured: 12 Months

  4. Number of Patients Alive at 2 Years (Survival)

    Participants who were alive at 2 years from date of enrollment.

    Measured: 24 Months

  5. Number of Patients Alive at 56 Months (End of Study)

    Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).

    Measured: Up to 56 months

Timeline

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

  1. First posted25 Jan 2006 (estimated)
  2. Study startMay 2002
  3. Primary completionMar 2008
  4. Study completionJul 2008

Why it stopped: Due to drug unavailability

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281827
Sponsor's protocol ID
2002LS013
Other IDs
LILLY-X-382, 0202M17981
Status last verified
Dec 2017
First submitted
24 Jan 2006
Last updated
28 Dec 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, gemcitabine hydrochloride and thalidomide in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 3 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?

The sponsor lists 13 inclusion and 16 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: stopped early, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 3 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Reporting Clinical Response (time frame: At end of 3 -21 day cycles of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281827.

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 Dec 2017.

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