CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Fase
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Cattedra di studio: John J. Rinehart, MD, University of Alabama at Birmingham
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- carcinoma mammario in stadio IV
- carcinoma mammario in stadio IIIA
- carcinoma mammario ricorrente
- carcinoma mammario in stadio IIIB
- carcinoma polmonare non a piccole cellule ricorrente
- carcinoma polmonare non a piccole cellule in stadio IIIA
- carcinoma polmonare non a piccole cellule in stadio IIIB
- carcinoma polmonare non a piccole cellule in stadio IV
- carcinoma del colon in stadio IV
- tumore al colon ricorrente
- carcinoma pancreatico ricorrente
- cancro al colon in stadio III
- carcinoma pancreatico in stadio IV
- carcinoma pancreatico in stadio III
- adenocarcinoma a cellule duttali del pancreas
- carcinoma pancreatico in stadio II
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Malattie della pelle
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Malattie del sistema endocrino
- Neoplasie dell'apparato digerente
- Neoplasie delle ghiandole endocrine
- Malattie del seno
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Malattie pancreatiche
- Neoplasie mammarie
- Neoplasie polmonari
- Neoplasie pancreatiche
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- CDR0000069279
- UAB-0152
- PFIZER-1040-002-004
- UAB-F011203011
- NCI-G02-2052
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