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Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

13. august 2010 oppdatert av: Case Comprehensive Cancer Center

A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which treatment regimen is more effective for stage IIIB or stage IV non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine and carboplatin followed immediately by docetaxel with that of giving delayed docetaxel in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

Primary

  • Compare the overall survival of patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine and carboplatin followed by immediate vs delayed docetaxel.

Secondary

  • Compare the response rate and time to progression in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance status (0 or 1 vs 2).

All patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients with stable or responding disease proceed to docetaxel therapy. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
  • Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life (QOL) is assessed at baseline, at restaging (after completion of gemcitabine and carboplatin), before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment.

NOTE: *For patients randomized to delayed docetaxel, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel

Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study.

Studietype

Intervensjonell

Registrering (Faktiske)

17

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Ohio
      • Cleveland, Ohio, Forente stater, 44106-5065
        • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IIIB with pleural effusion OR stage IV disease
    • Recurrent disease after primary treatment with radiotherapy or surgery allowed
  • Measurable disease or nonmeasurable disease

    • Measurable disease, defined as at least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Nonmeasurable disease, defined as all other lesions, including small lesions (longest diameter less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan) or any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Cystic lesions
      • Abdominal masses not confirmed and followed by imaging techniques
  • No symptomatic CNS metastases

    • Treated, stable CNS metastases allowed provided patient is not receiving radiotherapy or corticosteroids

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 3.0 times upper limit of normal (ULN) (less than 5.0 times ULN for patients with documented benign disease)
  • Alkaline phosphatase less than 3.0 times ULN (for patients with documented benign disease)

Renal

  • Creatinine no greater than 1.5 mg/dL

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active and ongoing infection
  • No concurrent serious systemic disorder that would preclude study participation
  • No other primary malignancy within the past 5 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in remission

    • Other prior cancers unlikely to affect survival for the next 3 years (e.g., low-grade early stage prostate cancer) are allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy for NSCLC, including neoadjuvant and adjuvant therapy
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent antitumor hormonal therapy (excluding contraceptives and replacement steroids)

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • Prior radiotherapy to less than 25% of bone marrow allowed provided the irradiated area is not the only site of measurable disease
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 3 weeks since prior therapy for cancer
  • More than 4 weeks since prior investigational agents
  • No other concurrent experimental medications
  • No other concurrent therapy for cancer

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Immediate Docetaxel
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
Carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.

Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Aktiv komparator: Delayed Docetaxel
Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
Carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.

Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Survival
Tidsramme: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter

Sekundære resultatmål

Resultatmål
Tidsramme
Response rate (partial and complete response)
Tidsramme: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
Time to progression
Tidsramme: treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.
treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.
Toxicity as measured by NCI CTC
Tidsramme: at baseline and at the end of each course not at day 8
at baseline and at the end of each course not at day 8
Quality of life as measured by the lung cancer symptom scale
Tidsramme: At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.
At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Nathan Levitan, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2003

Primær fullføring (Faktiske)

1. august 2005

Studiet fullført (Faktiske)

1. april 2008

Datoer for studieregistrering

Først innsendt

10. desember 2003

Først innsendt som oppfylte QC-kriteriene

10. desember 2003

Først lagt ut (Anslag)

11. desember 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. august 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2010

Sist bekreftet

1. august 2010

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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