AZD2171 and Standard Combination Chemotherapy in Advanced Non-Small Cell Lung Cancer or Colorectal Cancer

NCT00343408 | Completed Phase 1 DMC

• 3 other identifiers: I175CAN-NCIC-IND175CDR0000481443
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colorectal Cancer; Lung Cancer

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

Interventions

cediranib maleate DRUG

cisplatin DRUG

fluorouracil DRUG

gemcitabine hydrochloride DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 with no evidence of disease for ≥ 5 years * No untreated and/or uncontrolled cardiovascular conditions or symptomatic cardiac dysfunction * No resting blood pressure (BP) consistently higher than systolic BP \> 150 mm Hg and diastolic BP \> 100 mm Hg (in the presence or absence of a stable dose of antihypertensive medication) * No poorly controlled hypertension, history of labile hypertension, or poor compliance with antihypertensive medication * No overt bleeding (≥ 30 mL bleeding/episode) within the past 3 months * No clinically relevant hemoptysis (≥ 5 mL fresh blood) within the past 4 weeks * Flecks of blood in sputum allowed * No active or uncontrolled infections * No serious illnesses or medical conditions that would preclude compliance with study requirements * No mean QTc with Bazett's correction \> 470 msec * No history of familial long QT syndrome * No peripheral neuropathy \> grade 1 * No dihydropyrimidine dehydrogenase deficiency or history of severe hand-foot syndrome after fluoropyrimidines (for patients with CRC) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * At least 6 months since prior adjuvant or neoadjuvant therapy * At least 6 months since prior adjuvant radiotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) (for patients with NSCLC) * At least 4 weeks since prior and no concurrent corticosteroids * At least 3 weeks since prior palliative radiotherapy and recovered * Concurrent palliative radiotherapy allowed * At least 2 weeks since prior epidermal growth factor receptor inhibitor therapy * At least 2 weeks since prior major surgery * No more than 1 prior single-agent, nonplatinum-containing chemotherapy regimen for metastatic disease (for patients with NSCLC) * No prior gemcitabine hydrochloride (for patients with NSCLC) * No prior oxaliplatin (for patients with CRC) * No prior angiogenesis inhibitor * No prior chemotherapy for advanced/metastatic disease (for patients with CRC) * No other concurrent experimental drugs or anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (3)

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• Chen E, Jonker D, Gauthier I, MacLean M, Wells J, Powers J, Seymour L. Phase I study of cediranib in combination with oxaliplatin and infusional 5-Fluorouracil in patients with advanced colorectal cancer. Clin Cancer Res. 2009 Feb 15;15(4):1481-6. doi: 10.1158/1078-0432.CCR-08-0761.

  PMID: 19228749 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Colonic Neoplasms; Rectal Neoplasms

Interventions

cediranib; Cisplatin; Fluorouracil; Gemcitabine; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Gerald Batist, MD

  Jewish General Hospital

  STUDY CHAIR

• Eric X. Chen, MD, PhD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

• Glenwood D. Goss, MD, BCh, FCP, FRCPC

  Ottawa Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 23, 2006
• Study Start: November 29, 2005
• Primary Completion: September 18, 2007
• Study Completion: September 22, 2008
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)