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ZD0473 in Treating Patients With Progressive or Relapsed Non-Small Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
picoplatin
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Progressive or relapsed disease after first-line platinum-based chemotherapy Measurable disease No intracerebral metastases (unless asymptomatic, no corticosteroids required, and diagnostic imaging demonstrates no peritumoral edema or progression) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.25 times the upper limit of normal (ULN) ALT or AST less than 2.5 times ULN (5 times ULN if liver metastases present) No hepatic impairment No risk of hepatitis B transmission Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No currently unstable or uncompensated cardiac conditions Pulmonary: No currently unstable or uncompensated respiratory conditions Other: No risk of HIV transmission No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No other severe or uncontrolled systemic disease No infectious condition No significant clinical disorder that would preclude study Body surface area at least 1.2 m2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception for 3 months before, during, and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: No prior extensive radiotherapy to 30% or more of bone marrow (e.g., whole of pelvis or half of spine) Surgery: Recovered from prior surgery Other: At least 2 weeks since prior systemic anticancer therapy and recovered

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2001
    Last Updated
    December 18, 2013
    Sponsor
    Jonsson Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00021008
    Brief Title
    ZD0473 in Treating Patients With Progressive or Relapsed Non-Small Lung Cancer
    Official Title
    A Phase II Open, Multicenter Trial to Assess the Activity and Tolerability of ZD0473 Given Intravenously as Second-line Therapy to Patients With Non-Small Lung Cancer Who Have Failed One Prior Platinum Based Chemotherapy Regimen
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2001
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Jonsson Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ZD0473 in treating patients who have progressive or relapsed non-small cell lung cancer.
    Detailed Description
    OBJECTIVES: I. Determine the anti-tumor effect of ZD0473 in patients with progressive or relapsed non-small cell lung cancer who have failed first-line platinum-based chemotherapy. II. Assess the safety and tolerability of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the efficacy of this drug, in terms of time to death, time to disease progression, disease control, and duration of response, in these patients. V. Assess the therapy outcome index, in terms of disease-related symptom relief, of these patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to time to relapse or progression after completion of first-line platinum-based chemotherapy (12 weeks or less vs more than 12 weeks). Patients receive ZD0473 IV over 1 hour on day 1. Treatment repeats every 21 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, and then every 6 weeks for 1 year after completion of study. Patients are followed at 30 days after study completion and every 6 weeks for 1 year. PROJECTED ACCRUAL: A total of 32-73 patients (23-56 per stratum 1 and 9-17 per stratum 2) will be accrued for this study within approximately 9 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    picoplatin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Progressive or relapsed disease after first-line platinum-based chemotherapy Measurable disease No intracerebral metastases (unless asymptomatic, no corticosteroids required, and diagnostic imaging demonstrates no peritumoral edema or progression) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.25 times the upper limit of normal (ULN) ALT or AST less than 2.5 times ULN (5 times ULN if liver metastases present) No hepatic impairment No risk of hepatitis B transmission Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No currently unstable or uncompensated cardiac conditions Pulmonary: No currently unstable or uncompensated respiratory conditions Other: No risk of HIV transmission No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No other severe or uncontrolled systemic disease No infectious condition No significant clinical disorder that would preclude study Body surface area at least 1.2 m2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception for 3 months before, during, and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: No prior extensive radiotherapy to 30% or more of bone marrow (e.g., whole of pelvis or half of spine) Surgery: Recovered from prior surgery Other: At least 2 weeks since prior systemic anticancer therapy and recovered
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert A. Figlin, MD, FACP
    Organizational Affiliation
    Jonsson Comprehensive Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    ZD0473 in Treating Patients With Progressive or Relapsed Non-Small Lung Cancer

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