The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00243347
• Collaborator: (none)
• Enrollment: 19
• Locations: 2
• Duration (Months): 43
• Patients Per Site: 9.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma; Non-Small-Cell Lung Carcinoma; Head and Neck Neoplasms	Drug: AZD2171	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory, Open-Lael Study to Assess the Effects of AZD2171 on Tumors and Biomarkers in Patients With Previously Untreated or Recurrent Non-small Cell Lung Cancer (NSCLC) or Patients With Metastatic or Recurrent Head and Neck Cancer (HNC)
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Jul 1, 2009

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) [Randomisation until Day 22]

   Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)*100

Secondary Outcome Measures

1. Change From Baseline in Mean Arterial Blood Pressure (MAP) [Randomisation until Day 22]

   Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable stage IIIb or IV non-small cell lung cancer (NSCLC)

• At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET Scan

• Considered suitable for treatment of NSCLC with no prior biological or immunological therapy for disease

• Or considered suitable for treatment for metastatic or recurrent HNC with no prior biological or immunological therapy for disease

Exclusion Criteria:

• NSCLC: Have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of AZD2171

• HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of AZD2171

• Untreatable, unstable brain or meningeal metastases.

• Abnormal liver and kidney blood chemistries

• History of poorly controlled hypertension with resting blood pressure of >150/100

• Recent (< 14 days) major surgery or a surgical incision not fully healed

• Diabetes patients with type I insulin dependent diabetes or poorly controlled type II

• Significant hemorrhage or hemoptysis

• Presence of necrotic/hemorrhagic tumor or metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Houston	Texas	United States
2	Research Site	Barcelona		Spain

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: AstraZeneca Oncology Medical Sciences Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00243347
• Other Study ID Numbers: D8480C00015
• First Posted: Oct 24, 2005
• Last Update Posted: Oct 17, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by AstraZeneca: RECENTIN
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Cediranib

Study Results

Participant Flow

Arm/Group Title	Cediranib 30 mg
Arm/Group Description	Cediranib 30mg/Day
Period Title: Overall Study
STARTED	19
COMPLETED	0
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Cediranib 30 mg
Arm/Group Description	Cediranib 30mg/Day
Overall Participants	19
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.1 (12.32)
Sex: Female, Male (Count of Participants)
Female	4 21.1%
Male	15 78.9%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)
Description	Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)*100
Time Frame	Randomisation until Day 22

Outcome Measure Data

Analysis Population Description

Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis. To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit.

Arm/Group Title	Cediranib 30 mg
Arm/Group Description	Cediranib 30mg/Day
Measure Participants	17
Geometric Mean (95% Confidence Interval) [Percentage change in SUVmax]	-18.386

2. Secondary Outcome

Title	Change From Baseline in Mean Arterial Blood Pressure (MAP)
Description	Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).
Time Frame	Randomisation until Day 22

Outcome Measure Data

Analysis Population Description

Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.

Arm/Group Title	Cediranib 30 mg
Arm/Group Description	Cediranib 30mg/Day
Measure Participants	17
Mean (95% Confidence Interval) [mmHg]	6.853 (1.010)

Adverse Events

Arm/Group Title	Cediranib 30 mg
Arm/Group Description	Cediranib 30mg/Day
All Cause Mortality
	Cediranib 30 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cediranib 30 mg
	Affected / at Risk (%)	# Events
Total	3/19 (15.8%)
Blood and lymphatic system disorders
Anaemia	1/19 (5.3%)
Gastrointestinal disorders
Nausea	1/19 (5.3%)
Tongue Haemorrhage	1/19 (5.3%)
Vomiting	1/19 (5.3%)
Metabolism and nutrition disorders
Hypovolaemia	1/19 (5.3%)
Respiratory, thoracic and mediastinal disorders
Acquired Tracheo-Oesophageal Fistula	1/19 (5.3%)
Other (Not Including Serious) Adverse Events
	Cediranib 30 mg
	Affected / at Risk (%)	# Events
Total	18/19 (94.7%)
Blood and lymphatic system disorders
Lymphopenia	1/19 (5.3%)
Cardiac disorders
Pericardial Effusion	1/19 (5.3%)
Endocrine disorders
Hyperthyroidism	1/19 (5.3%)
Gastrointestinal disorders
Diarrhoea	8/19 (42.1%)
Enteritis	3/19 (15.8%)
Nausea	3/19 (15.8%)
Vomiting	3/19 (15.8%)
Stomatitis	2/19 (10.5%)
Abdominal Distension	1/19 (5.3%)
Abdominal Pain	1/19 (5.3%)
Dry Mouth	1/19 (5.3%)
Dyspepsia	1/19 (5.3%)
Dysphagia	1/19 (5.3%)
Gingival Bleeding	1/19 (5.3%)
Oral Pain	1/19 (5.3%)
General disorders
Fatigue	6/19 (31.6%)
Asthenia	4/19 (21.1%)
Chest Discomfort	1/19 (5.3%)
Chest Pain	1/19 (5.3%)
Localised Oedema	1/19 (5.3%)
Oedema Peripheral	1/19 (5.3%)
Pyrexia	1/19 (5.3%)
Infections and infestations
Oral Candidiasis	1/19 (5.3%)
Pneumonia	1/19 (5.3%)
Injury, poisoning and procedural complications
Limb Injury	1/19 (5.3%)
Blood Corticotrophin Increased	4/19 (21.1%)
Weight Decreased	4/19 (21.1%)
Blood Thyroid Stimulating Hormone Increased	2/19 (10.5%)
Blood Thyroid Stimulating Hormone Decreased	1/19 (5.3%)
Haemoglobin Decreased	1/19 (5.3%)
Urine Colour Abnormal	1/19 (5.3%)
White Blood Cell Count Decreased	1/19 (5.3%)
Metabolism and nutrition disorders
Anorexia	3/19 (15.8%)
Dehydration	3/19 (15.8%)
Hyperglycaemia	2/19 (10.5%)
Hypercholesterolaemia	1/19 (5.3%)
Hypertriglyceridaemia	1/19 (5.3%)
Hyperuricaemia	1/19 (5.3%)
Hypokalaemia	1/19 (5.3%)
Hypomagnesaemia	1/19 (5.3%)
Musculoskeletal and connective tissue disorders
Neck Pain	3/19 (15.8%)
Muscle Spasms	2/19 (10.5%)
Arthralgia	1/19 (5.3%)
Back Pain	1/19 (5.3%)
Myalgia	1/19 (5.3%)
Nervous system disorders
Aphonia	1/19 (5.3%)
Cervical Root Pain	1/19 (5.3%)
Dysarthria	1/19 (5.3%)
Headache	1/19 (5.3%)
Hypoaesthesia	1/19 (5.3%)
Migraine	1/19 (5.3%)
Neuropathy Peripheral	1/19 (5.3%)
Peripheral Sensory Neuropathy	1/19 (5.3%)
Psychiatric disorders
Depression	1/19 (5.3%)
Insomnia	1/19 (5.3%)
Renal and urinary disorders
Proteinuria	8/19 (42.1%)
Ketonuria	1/19 (5.3%)
Renal Failure	1/19 (5.3%)
Reproductive system and breast disorders
Menorrhagia	1/19 (5.3%)
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	3/19 (15.8%)
Dyspnoea	2/19 (10.5%)
Cough	1/19 (5.3%)
Epistaxis	1/19 (5.3%)
Pleural Effusion	1/19 (5.3%)
Skin and subcutaneous tissue disorders
Pruritus	3/19 (15.8%)
Rash	2/19 (10.5%)
Dry Skin	1/19 (5.3%)
Ecchymosis	1/19 (5.3%)
Palmar-Plantar Erythrodysaesthesia Syndrome	1/19 (5.3%)
Skin Reaction	1/19 (5.3%)
Vascular disorders
Hypertension	6/19 (31.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.