Phase I Safety and Tolerability Study of Cediranib (RECENTIN™, AZD2171) in Combination With Chemo in First Line Lung Cancer Patients

NCT00621361 | Completed Phase 1

• 1 other identifier: D8480C00054
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

Brief Summary

This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.

Conditions

Lung Cancer

Keywords

Lung Cancer; AZD2171; cediranib; RECENTIN; etoposide; cisplatin

Outcome Measures

Primary Outcomes (1)

• Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP).

  From date of consent through to data cut-off, 7th August 2009.

Secondary Outcomes (1)

• Preliminary efficacy assessment of Cediranib in combination with etoposide & cisplatin using available tumor assessment data to assess response rate,duration of response,change in tumor size(only those with measurable disease)& progression free survival

  From date of randomisation through to data cut-off, 7th August 2009.

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD2171

2

ACTIVE COMPARATOR

Etoposide + Cisplatin

Drug: Etoposide; Drug: Cisplatin

Interventions

AZD2171 DRUG

Oral

Also known as: Recentin™

1

Etoposide DRUG

Intravenous

Also known as: Etopophos®

2

Cisplatin DRUG

Intravenous

Also known as: Platinol

2

Eligibility Criteria

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

You may qualify if:

• Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.)
• No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.)
• WHO performance status 0-2

You may not qualify if:

• Untreated unstable brain or meningeal metastases
• Patient with inappropriate laboratory tests values
• Inadequate bone marrow reserve.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Sacramento, California, United States

Location

Research Site

Denver, Colorado, United States

Location

Research Site

Kansas City, Kansas, United States

Location

Research Site

Houston, Texas, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

cediranib; Etoposide; etoposide phosphate; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• John Heymach, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (4)