AZD2171 and Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer, Colorectal Cancer, or Other Cancer Suitable for Treatment With Capecitabine (Non-Small Lung Cancer Patients Closed to Enrollment as 8/9/07)
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | April 5, 2005 | ||||||||
Last Updated Date | January 18, 2011 | ||||||||
Start Date ICMJE | January 2005 | ||||||||
Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Dose limiting toxicity [ Time Frame: Each dose level ] [ Designated as safety issue: Yes ] To recommend phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colon cancer or other tumour types suitable for treatment with capecitabine. |
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00107250 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | AZD2171 and Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer, Colorectal Cancer, or Other Cancer Suitable for Treatment With Capecitabine (Non-Small Lung Cancer Patients Closed to Enrollment as 8/9/07) | ||||||||
Official Title ICMJE | A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumor Types Suitable for Treatment With Capecitabine | ||||||||
Brief Summary | RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, carboplatin, or capecitabine, 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 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 chemotherapy in treating patients with advanced non-small cell lung cancer (closed to enrollment as of 8/9/07), colorectal cancer, or other cancer suitable to capecitabine treatment. |
||||||||
Detailed Description | OBJECTIVES:
OUTLINE: This is an open-label, multicenter, dose-escalation study of AZD2171. Patients are assigned to 1 of 2 treatment groups according to diagnosis.
In both groups, patients achieving a complete response (CR) OR a stable partial response (SPR) receive 2 additional courses beyond CR or SPR. Cohorts of 3-6 patients per group receive escalating doses of AZD2171 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 30 additional patients (20 in group 1 and 10 in group 2) will be treated at the MTD. After completion of study treatment, patients are followed at 4 weeks and then every 3 months until disease relapse. PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study. |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE |
|
||||||||
Study Arm (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Enrollment ICMJE | 50 | ||||||||
Completion Date | January 2011 | ||||||||
Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | Canada | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00107250 | ||||||||
Other Study ID Numbers ICMJE | I171, CAN-NCIC-IND171, CDR0000422357 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Ralph Meyer, M.D., NCIC Clinical Trials Group | ||||||||
Study Sponsor ICMJE | NCIC Clinical Trials Group | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | NCIC Clinical Trials Group | ||||||||
Verification Date | January 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |