- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00033384
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: John J. Rinehart, MD, University of Alabama at Birmingham
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- stadium IV bröstcancer
- stadium IIIA bröstcancer
- återkommande bröstcancer
- stadium IIIB bröstcancer
- återkommande icke-småcellig lungcancer
- stadium IIIA icke-småcellig lungcancer
- stadium IIIB icke-småcellig lungcancer
- stadium IV icke-småcellig lungcancer
- stadium IV tjocktarmscancer
- återkommande tjocktarmscancer
- återkommande pankreascancer
- stadium III tjocktarmscancer
- stadium IV pankreascancer
- stadium III pankreascancer
- kanalcellsadenokarcinom i bukspottkörteln
- stadium II pankreascancer
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Hudsjukdomar
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Sjukdomar i det endokrina systemet
- Neoplasmer i matsmältningssystemet
- Neoplasmer i endokrina körtel
- Bröstsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Bukspottkörtelsjukdomar
- Bröstneoplasmer
- Lungneoplasmer
- Pankreatiska neoplasmer
Andra studie-ID-nummer
- CDR0000069279
- UAB-0152
- PFIZER-1040-002-004
- UAB-F011203011
- NCI-G02-2052
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