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CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer

10. april 2013 opdateret af: University of Alabama at Birmingham

A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer

RATIONALE: CI-1040 may stop the growth of tumors by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of CI-1040 in treating patients who have metastatic or unresectable breast, colon, pancreatic, or non-small cell lung cancer.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the antitumor activity of CI-1040 in patients with non-small cell lung, breast, colon, or pancreatic cancer.
  • Determine the safety profile of this drug in these patients.
  • Assess quality of life (overall and for each tumor type) of patients treated with this drug.
  • Determine the relationship between study drug concentration and antitumor response in these patients and target suppression and safety of this drug.
  • Correlate target suppression (pERK) with antitumor effects of this drug in these patients.
  • Correlate the mRNA expression profile of the tumors with antitumor effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (non-small cell lung vs breast vs colon vs pancreas).

Patients receive oral CI-1040 twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 28 days during the first 6 months of study therapy.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 52-172 patients (13-43 per stratum) will be accrued for this study.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic or inoperable non-small cell lung, breast, or colon cancer or duct cell carcinoma of the exocrine pancreas
  • Bidimensionally measurable lesions that are not previously irradiated

    • New lesions that have developed in a previously irradiated field may be used as measurable disease
  • No brain metastases

    • Patients with prior brain metastases are allowed provided they have undergone prior resection of metastases and/or 1 prior course of cranial irradiation, have no new sites of brain metastases since then, have no worsening CNS symptoms, and have discontinued prior corticosteroids for at least 30 days
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST or ALT no greater than 2 times ULN (5 times ULN if due to liver involvement)

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after study participation
  • Capable of swallowing intact study medication capsules
  • Capable of following instructions regarding study medication or has daily caregiver to administer study medication
  • No concurrent serious infection
  • No life-threatening illness unrelated to tumor
  • No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 2 weeks since prior immunotherapy or biologic therapy

Chemotherapy:

  • At least 4 weeks since prior cytotoxic chemotherapy
  • No more than 1 prior cytotoxic chemotherapy regimen for metastatic non-small cell lung or colon cancer
  • No more than 2 prior cytotoxic chemotherapy regimens for breast cancer
  • No prior cytotoxic chemotherapy for pancreatic cancer

Endocrine therapy:

  • See Disease Characteristics
  • At least 2 weeks since other prior hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent anticancer agents

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

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Studiestol: John J. Rinehart, MD, University of Alabama at Birmingham

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. februar 2002

Primær færdiggørelse (Faktiske)

1. november 2003

Studieafslutning (Faktiske)

1. november 2003

Datoer for studieregistrering

Først indsendt

9. april 2002

Først indsendt, der opfyldte QC-kriterier

7. juli 2003

Først opslået (Skøn)

8. juli 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2013

Sidst verificeret

1. december 2002

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystkræft

Kliniske forsøg med CI-1040

Abonner