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AzTrials

Lung CancerPhase 3NCT00112710

Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

A Phase 3 study testing carboplatin, cisplatin and gemcitabine hydrochloride in people with Lung Cancer, run by University Hospital Birmingham at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, 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 years and older
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, cisplatin and gemcitabine hydrochloride
How many people
1,350 participants
Where
2 sitesUnited Kingdom
Study dates
Mar 2005to not given
Phase
Phase 3
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 non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
  • Stage IIIB disease* that is not suitable for radical radiotherapy
  • Stage IV disease* NOTE: *Radiographically verified
  • At least 1 measurable lesion by clinical examination or radiography
  • No mixed histologies of small cell lung cancer and NSCLC
  • No clinically apparent brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • AST < 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Alkaline phosphatase < 3 times ULN
  • Bilirubin < 1.5 times ULN

Renal

  • Creatinine clearance ≥ 60 mL/min (by Wright equation) OR ≥ 70 mL/min (by ^51Cr-EDTA clearance)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able and willing to participate in the quality of life assessment
  • No pre-existing neuropathy > grade 2
  • No other malignancy that would preclude study treatment or study comparisons
  • No evidence of severe or uncontrolled systemic disease, significant clinical disorder, or laboratory finding that would preclude study participation
  • No psychiatric disorder that would preclude study participation
  • No other condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy except contraceptives or replacement steroids

Radiotherapy

  • No prior radiotherapy

Surgery

  • Recovered from prior surgery
  • Prior surgical resection for NSCLC allowed

Other

  • More than 12 weeks since prior investigational agents and recovered
  • No other concurrent specific antitumor therapy
  • No other concurrent investigational agents

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites, 2 recruiting

  • Institute of Clinical Research - Birmingham

    Birmingham, England, B15 2TT

    Hugh Jarrett, 44-121-414-6425

    Recruiting

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

    Joyce Thompson, 44-121-766-6611

    Recruiting

Other trials in United Kingdom

About this study

Official title: A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, 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. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin vs carboplatin, in terms of survival time, in patients with stage IIIB or IV non-small cell lung cancer.

Secondary

  • Compare symptom control and quality of life of patients treated with these regimens.
  • Compare response in patients treated with these regimens.
  • Compare the dose intensity of these regimens in these patients.
  • Compare the ratio of courses of treatment given as in-patient vs out-patient in these patients.
  • Compare the intensity and number and duration of toxic episodes in patients treated with these regimens.
  • Compare cost and cost-effectiveness of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 or 2), disease stage (IIIB vs IV), and participating center. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.
  • Arm II: Patients receive gemcitabine as in arm I and cisplatin (at a lower dose than in arm I) IV over 1 hour on day 1.
  • Arm III: Patients receive gemcitabine as in arm I and carboplatin IV over 1 hour on day 1.

In all arms, treatment repeats every 21 days for 2 courses. Patients are reassessed after 2 courses. Patients with responding disease or stable disease with symptom improvement receive 2 additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression or stable disease without symptom improvement are removed from the study.

Quality of life is assessed at baseline, on day 1 of courses 2-4, at completion of study treatment, and then monthly for 6 months.

After completion of study treatment, patients are followed monthly for 6 months and then periodically thereafter for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,350 patients (450 per treatment arm) will be accrued for this study within 6 years.

Conditions
Lung Cancer
Keywords
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. Length of survival

Secondary outcomes (6)

  1. Symptom control and quality of life as measured by the EORTC Quality of Life Questionnaire Core 30 Items and Lung Cancer supplement 13 together with EuroQol-5 domain questionnaire

  2. Treatment response as measured by RECIST criteria

  3. Dose intensity of chemotherapy

  4. Ratio of treatment courses given as in-patient versus out-patient

  5. Toxicity as measured by CTCAE v3.0

  6. Treatment cost

Timeline

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

  1. First posted3 Jun 2005 (estimated)
  2. Study startMar 2005

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 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
1,350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112710
Sponsor's protocol ID
CDR0000429610
Other IDs
CRUK-BTOG2-LU3005, EU-20510
Status last verified
May 2007
First submitted
2 Jun 2005
Last updated
26 Aug 2013
Results posted
No

Publications

  • Gijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2.

    PubMed 37419867

  • Ferry D, Billingham L, Jarrett H, Dunlop D, Woll PJ, Nicolson M, Shah R, Thompson J, Spicer J, Muthukumar D, Skailes G, Leonard P, Chetiyawardana AD, Wells P, Lewanski C, Crosse B, Hill M, Gaunt P, O'Byrne K. Carboplatin versus two doses of cisplatin in combination with gemcitabine in the treatment of advanced non-small-cell lung cancer: Results from a British Thoracic Oncology Group randomised phase III trial. Eur J Cancer. 2017 Sep;83:302-312. doi: 10.1016/j.ejca.2017.05.037. Epub 2017 Aug 4.

    PubMed 28780466

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, cisplatin and gemcitabine hydrochloride in people with Lung Cancer, run by University Hospital Birmingham at 2 sites in United Kingdom.

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: status not confirmed, as of the sponsor's last update on 26 Aug 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 Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of survival. 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 NCT00112710, which also lists 2 linked publications.

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 26 Aug 2013.

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