AZD2171 and Standard Combination Chemotherapy in Advanced Non-Small Cell Lung Cancer or Colorectal Cancer
Condition: Colorectal Cancer; Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the recommended phase II dose of AZD2171 when administered with standard
           combination chemotherapy in patients with advanced non-small cell lung cancer or
           colorectal cancer.

        -  Determine the safety, tolerability, toxicity profile, dose-limiting toxicities, and
           pharmacokinetic profile of this treatment regimen.

        -  Assess the antitumor activity of this treatment regimen in patients with measurable
           disease.

        -  Correlate the toxicity profile with pharmacokinetics.

      OUTLINE: This is a multicenter, open-label, dose-escalation study of AZD2171. Patients are
      assigned to 1 of 2 treatment groups according to disease.

        -  Group 1 (non-small cell lung cancer): Patients receive gemcitabine hydrochloride IV on
           days 1 and 8 and cisplatin IV on day 1. Patients also receive oral AZD2171 once daily
           beginning on day 2. Treatment repeats every 21 days in the absence of disease
           progression or unacceptable toxicity.

        -  Group 2 (colorectal cancer): Patients receive oxaliplatin IV over 2 hours and leucovorin
           calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days
           1 and 2. Patients also receive oral AZD2171 once daily beginning on day 3. Treatment
           repeats every 14 days in the absence of disease progression or unacceptable toxicity.

      In both groups, cohorts of 3-6 patients receive escalating doses of AZD2171 until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at
      least 2 of 6 patients experience dose-limiting toxicity.

      After completion of study treatment, patients are followed at 4 weeks and then every 3 months
      thereafter.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): cediranib maleate; cisplatin; fluorouracil; gemcitabine hydrochloride; leucovorin calcium; oxaliplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Gemcitabine; Fluorouracil; Oxaliplatin; Cediranib; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent colon cancer; stage III colon cancer; stage IV colon cancer; recurrent rectal cancer; stage III rectal cancer; stage IV rectal cancer