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Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

19. august 2008 opdateret af: Pharmacyclics LLC.

Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer

The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: Motexafin Gadolinium

Detaljeret beskrivelse

Outline:

Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms:

Arm A - 10 mg/kg MGd once per week

Arm B - 15 mg/kg MGd once every 3 weeks

Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study.

At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

108

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Canada
- Alberta
  - Calgary, Alberta, Canada
  - Edmonton, Alberta, Canada
- Ontario
  - Kingston, Ontario, Canada
  - Ottawa, Ontario, Canada
- Quebec
  - Montreal, Quebec, Canada
Forenede Stater
- California
  - Fountain Valley, California, Forenede Stater
  - Los Angeles, California, Forenede Stater
  - Palm Springs, California, Forenede Stater
- Missouri
  - Columbia, Missouri, Forenede Stater
  - St. Louis, Missouri, Forenede Stater
- Nebraska
  - Omaha, Nebraska, Forenede Stater
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater
- New York
  - Rochester, New York, Forenede Stater
- Ohio
  - Akron, Ohio, Forenede Stater
- Tennessee
  - Knoxville, Tennessee, Forenede Stater
  - Nashville, Tennessee, Forenede Stater

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

>18 years old
Histologically or cytologically confirmed diagnosis of NSCLC
Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
ECOG performance status score of 0 or 1
Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory values of:
- Absolute neutrophil count < 1500/ul;
- Platelet count < 75,000/ul;
- Hemoglobin < 10 gm/dl;
- AST or ALT > 3 x the upper limit of normal (ULN);
- Alkaline phosphatase > 5 x ULN;
- Bilirubin > 2 x ULN;
- Serum creatinine > 2.0 mg/dL.
Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis.
Evidence of meningeal metastasis.
Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen).
Chemotherapy, radiation therapy, experimental therapy, immunotherapy or systemic biologic anticancer therapy within 21 days before beginning study treatment.
Significant weight loss > 10% of body weight in preceding 6 weeks.
Treatment for another cancer within 3 years of enrollment, unless basal cell carcinoma or cervical cancer in situ.
Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association (NYHA) Class III or IV.
Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood pressure > 110 mm Hg on maximal medical therapy).
Known history of porphyria (testing not required at screening visit).
Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit).
Known history of HIV infection (testing not required at screening visit).
Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential).
Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection.
Physical or mental condition that makes patient unable to complete specified follow-up assessments.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC

Sekundære resultatmål

Resultatmål
To select the most effective regimen based on tumor response
To estimate the time to progression
To estimate survival
To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pharmacyclics LLC.

Efterforskere

Studiestol: Robert Natale, M.D., Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2005

Primær færdiggørelse (Faktiske)

1. juni 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

10. august 2005

Først indsendt, der opfyldte QC-kriterier