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)

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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)
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2008
Sponsored by: National Cancer Institute of Canada

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00107250

Purpose
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.



Condition Intervention Phase
Colorectal Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: capecitabine
Drug: carboplatin
Drug: cediranib maleate
Drug: paclitaxel
Phase I




MedlinePlus related topics: Cancer Colorectal Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel Capecitabine Cediranib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: 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


Further study details as provided by National Cancer Institute (NCI):


Estimated Enrollment: 35
Study Start Date: January 2005
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

Determine the maximum tolerated dose and recommended phase II dose of AZD2171 when administered in combination with standard chemotherapy comprising either paclitaxel and carboplatin OR capecitabine in patients with advanced incurable non-small cell lung cancer (closed to accrual as of 8/9/07), colorectal cancer, or other tumor types suitable for treatment with capecitabine.
Determine the safety and tolerability of these regimens in these patients.
Determine the toxicity profile and dose-limiting toxic effects of these regimens in these patients.
Determine the pharmacokinetic profile of these regimens in these patients.
Correlate the toxicity profile with the pharmacokinetic profile of these regimens in these patients.
Determine the antitumor activity of these regimens in patients with measurable disease.
Correlate patient outcome (response) with baseline (using tumor samples) and serial (using urine and plasma samples) biomarkers in patients treated with these regimens.
OUTLINE: This is an open-label, multicenter, dose-escalation study of AZD2171. Patients are assigned to 1 of 2 treatment groups according to diagnosis.

Group 1 (non-small cell lung cancer) (closed to accrual as of 8/9/07): Patients receive paclitaxel IV and carboplatin IV on day 1. Patients also receive oral AZD2171 once daily on days 2-21 of course 1 and on days 1-21 of all subsequent courses. Treatment with paclitaxel and carboplatin repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Group 2 (colorectal or other tumor types): Patients receive oral capecitabine twice daily on days 1-14. Patients also receive oral AZD2171 once daily on days 8-21 of course 1 and on days 1-21 of all subsequent courses. Treatment with capecitabine repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed diagnosis of 1 of the following:

Non-small cell lung cancer (NSCLC) (closed to accrual as of 8/9/07) meeting 1 of the following stage criteria:

Stage IIIB disease

Patients without pleural effusion who are not candidates for combined modality treatment OR who were treated at centers where combined modality treatment is not considered standard treatment are eligible
Stage IV disease
Local or metastatic failure after prior surgery and/or radiotherapy
Colorectal cancer

Metastatic disease
Considered suitable for first-line therapy with capecitabine
Other tumor types

Suitable for treatment with capecitabine
No more than 2 prior chemotherapy regimens for advanced or metastatic disease
Incurable by radiotherapy or surgery
Clinically or radiologically documented disease

No tumor marker elevation as the only evidence of disease
No necrotic or hemorrhagic tumor or metastases
No untreated brain or meningeal metastases

Patients with previously treated stable brain metastases (by radiography or clinical exam) are eligible provided they are asymptomatic and do not require corticosteroids
PATIENT CHARACTERISTICS:

Age

18 and over
Performance status

ECOG 0-2
Life expectancy

At least 12 weeks (colorectal cancer patients)
Hematopoietic

Hemoglobin adequate

Anemia allowed provided patient is well compensated with no evidence of recent bleeding
Absolute granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
No overt bleeding (i.e., ≥ 30 mL/episode) within the past 3 months
Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT or AST ≤ 2 times ULN (5 times ULN for documented liver metastases)
Renal

Creatinine ≤ 1.5 times ULN OR
Creatinine clearance ≥ 50 mL/min
No proteinuria > grade 1
Cardiovascular

Resting systolic blood pressure ≤ 150 mm Hg AND/OR resting diastolic blood pressure ≤ 100 mm Hg (in the presence or absence of a stable dose of antihypertensive medication)
Mean QTc ≤ 470 msec (with Bazetts correction) by ECG
LVEF > 50% for patients with prior anthracyclines/trastuzumab or cardio-toxic agents
No untreated or uncontrolled cardiovascular condition
No symptomatic cardiac dysfunction
No poorly controlled hypertension
No history of labile hypertension
No history of poor compliance with antihypertensive medication
No history of familial long QT syndrome
Pulmonary

No clinically relevant hemoptysis (i.e., ≥ 5 mL fresh blood) within the past 4 weeks

Patients with only flecks of blood in their sputum are eligible
Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective (double-method for females; barrier method for males) contraception
No prior allergic reaction to drugs containing Cremophor EL® (NSCLC patients [closed to accrual as of 8/9/07])
No peripheral neuropathy > grade 1 (NSCLC patients [closed to accrual as of 8/9/07])
No dihydropyrimidine dehydrogenase deficiency (colorectal cancer patients)
No history of severe hand-foot syndrome after treatment with fluoropyrimidines (colorectal cancer patients)
No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or other curatively treated solid tumor
No active or uncontrolled infection
No other serious illness or medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior antiangiogenesis therapy
Chemotherapy

At least 4 weeks since prior single-agent non-platinum-containing chemotherapy (6 weeks for nitrosoureas or mitomycin) for metastatic disease (NSCLC patients [closed to accrual as of 8/9/07])

No more than 1 prior single-agent non-platinum-containing chemotherapy regimen for metastatic disease
At least 6 months since prior adjuvant or neoadjuvant chemotherapy
No prior taxane therapy (NSCLC patients [closed to accrual as of 8/9/07])
No prior chemotherapy for metastatic disease (colorectal cancer patients)
No prior capecitabine (colorectal cancer patients)
Endocrine therapy

See Disease Characteristics
At least 4 weeks since prior corticosteroids
Radiotherapy

See Disease Characteristics
At least 21 days since prior palliative radiotherapy except for low-dose non-myelosuppressive radiotherapy with approval
At least 6 months since prior adjuvant radiotherapy
Surgery

See Disease Characteristics
At least 14 days since prior major surgery
Other

Recovered from prior therapy
At least 14 days since prior epidermal growth factor receptor inhibitor therapy
Concurrent oral anticoagulants (e.g., warfarin) allowed provided INR is strictly monitored
No other concurrent investigational therapy
No other concurrent anticancer therapy
No concurrent prophylactic pyridoxine (vitamin B_6) for hand-foot syndrome (colorectal or other tumor type patients)

Use of pyridoxine after the onset of hand-foot syndrome allowed at the discretion of the physician
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107250


Locations
Canada, Ontario
Ottawa Hospital Regional Cancer Centre - General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Scott Laurie 613-737-7700
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Eric (Xueyu) Chen 416-946-2263

Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Derek Jonker, MD Ottawa Hospital Regional Cancer Centre - General Campus
Investigator: Scott A. Laurie, MD, FRCPC Ottawa Hospital Regional Cancer Centre - General Campus

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000422357, CAN-NCIC-IND171
Study First Received: April 5, 2005
Last Updated: December 6, 2008
ClinicalTrials.gov Identifier: NCT00107250 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
stage IV colon cancer
stage IV rectal cancer
unspecified adult solid tumor, protocol specific



Study placed in the following topic categories:
Thoracic Neoplasms
Capecitabine
Non-small cell lung cancer
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases
Carboplatin
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal neoplasm
Carcinoma
Digestive System Diseases
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Rectal cancer
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial



Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic



ClinicalTrials.gov processed this record on February 10, 2009


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