AZD2171 and Standard Combination Chemotherapy in Advanced Non-Small Cell Lung Cancer or Colorecta… (NCT00343408) | Clinical Trial Compass
CompletedPhase 1
AZD2171 and Standard Combination Chemotherapy in Advanced Non-Small Cell Lung Cancer or Colorectal Cancer
Canada31 participantsStarted 2005-11-29
Plain-language summary
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2171 together with standard combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of AZD2171 when given together with standard combination chemotherapy in treating patients with advanced non-small cell lung cancer (NSCLC) or colorectal cancer.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Non-small cell lung cancer (NSCLC), meeting 1 of the following criteria:
* Stage IIIB disease
* No pleural effusion and not a candidate for a combined modality treatment
* Stage IV disease
* Local or metastatic failure after surgery and/or radiotherapy
* Colorectal cancer (CRC)
* Advanced and/or metastatic disease
* Suitable for first-line therapy with oxaliplatin, leucovorin calcium, and fluorouracil (FOLFOX-6)
* Clinically or radiologically documented disease
* No tumor marker elevation as sole evidence of disease
* No necrotic/hemorrhagic metastases or tumor
* No untreated brain or meningeal metastases
* Previously treated, radiologic or clinical evidence of stable brain metastases allowed provided disease is asymptomatic and corticosteroids are not required
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Hemoglobin normal
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
* Bilirubin ≤ 1.5 times ULN
* AST or ALT ≤ 2 times ULN (5 times ULN if liver involvement)
* Proteinuria ≤ grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of other malignancies except adequately treated nonmelanoma skin cancer or other solid tumors curatively treated w…