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Lung CancerPhase 2NCT00305786

Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

A Phase 2 study testing gemcitabine hydrochloride and oxaliplatin in people with Lung Cancer, run by University of Miami 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: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
gemcitabine hydrochloride and oxaliplatin
How many people
30 participants
Where
2 sitesUnited States
Study dates
Aug 2005to May 2010
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven stage IIIB or IV non-small cell lung cancer (NSCLC)
  • Failed first-line chemotherapy
  • Must have received ≥ 1, but no more than 2, prior chemotherapy regimens for stage IIIB or IV NSCLC
  • Prior radiotherapy or surgery for earlier stage disease allowed, provided target lesions chosen for response assessment have not have been irradiated
  • At least 1 unidimensionally measurable lesion with diameter ≥ 20 mm by conventional methods OR ≥ 10 mm by spiral CT scan
  • If a single lesion is identified as the target lesion, histological or cytological confirmation of this lesion is required
  • No symptomatic brain metastases
  • Clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0 or 1
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement)
  • Creatinine ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after completion of study treatment
  • No history of an acute cardiac or CNS event within the past 6 months, including any of the following:
  • Unstable angina
  • Myocardial infarction
  • Clinically relevant arrhythmia
  • Stroke
  • No current clinical evidence of congestive heart failure or unstable coronary artery disease
  • No peripheral neuropathy > grade 1
  • No history of hypersensitivity to study drugs
  • No serious uncontrolled medical or psychiatric illness, including any of the following:
  • Serious infection
  • Interstitial pneumonia
  • Extensive and symptomatic fibrosis of the lung
  • No other malignancy within the past year, except for squamous cell or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery
  • At least 4 weeks since prior cranial radiation for brain metastases
  • More than 4 weeks since prior participation in another investigational drug study
  • No concurrent immunotherapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

Other trials in United States

About this study

Official title: Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, 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.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy and safety of gemcitabine hydrochloride and oxaliplatin as second-line chemotherapy in patients with stage IIIB or IV non-small cell lung cancer.
  • Determine overall response in patients treated with this regimen.

Secondary

  • Determine time to progression, time to treatment failure, and overall survival of these patients.
  • Determine the type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days after completion of study treatment.
  • Assess the quality of life of these patients.
  • Determine the expression of RRM1 and ERCC1 in peripheral blood mononuclear cells from these patients.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the beginning of each course, at the completion of study treatment, and then every 6 weeks thereafter.

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

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

What is being measured

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

  1. Response rate as measured by RECIST criteria

    Measured: At study completion

Secondary outcomes (1)

  1. Toxicity as monitored by DSMC

    Measured: At study completion

Timeline

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

  1. First posted22 Mar 2006 (estimated)
  2. Study startAug 2005
  3. Primary completionDec 2007
  4. Study completionMay 2010

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00305786
Sponsor's protocol ID
20043597
Other IDs
SCCC-2004078, WIRB-20050485
Status last verified
Dec 2016
First submitted
21 Mar 2006
Last updated
15 Dec 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and oxaliplatin in people with Lung Cancer, run by University of Miami 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 15 Dec 2016. 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?

Response rate as measured by RECIST criteria (time frame: At study completion). 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 NCT00305786.

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 15 Dec 2016.

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