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AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer

Phase II Study of AZD0530 (NSC 735464) in Patients With Previously Treated Metastatic Colorectal Cancer

NCT00397878•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial is studying how well AZD0530 works in treating patients with previously treated metastatic colon cancer or rectal cancer. AZD0530 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.

Detailed Description

PRIMARY OBJECTIVES: I. Determine the progression-free survival (PFS) at 4 months in metastatic colorectal carcinoma patients receiving daily doses of AZD0530. SECONDARY OBJECTIVES: I. Evaluate the objective response rate (RR) and overall survival (OS) of patients with metastatic colorectal cancer who are treated with AZD0530. II. In patients who consent, both blood and tissue samples will be collected for laboratory correlates. Assess in a preliminary manner the association between correlative markers and the potential downstream effects of AZD0530 on IL-8, VEGF, specific Src-regulated markers in focal adhesions, adherens junctions, and angiogenesis on clinical outcome in pre- and post-treatment tumor samples. OUTLINE: Patients receive oral AZD0530 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic
•Patients must have measurable disease, defined (per RECIST criteria) as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or \>= 10 mm with spiral CT scan
•Patients must have received one and only one prior chemotherapy regimen for metastatic colorectal cancer; patients may have received biologic therapy (e.g., bevacizumab) in combination with chemotherapy as part of their prior chemotherapy
•ECOG performance status 0-2
•Absolute neutrophil count (ANC) \>= 1,500/mcL
•Platelets \>= 100,000/mcL
•Hemoglobin \>= 9 g/dL
•Total bilirubin =\< 1.5 x institutional ULN
•AST(SGOT)/ALT(SGPT) =\< 3.0 x institutional ULN
•Creatinine within normal institutional limits OR estimated CrCl (Cockcroft-Gault) or 24 hr urine collection of \>= 50 mL/min
+3 more criteria

Exclusion Criteria

•Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study registration or those who have not recovered from treatment related adverse events \> grade 1 (except for neuropathy \[ies\] which may be =\< grade 2) due to agents administered more than 4 weeks earlier
•Patients may not be receiving any other investigational agents
•Patients with greater than +1 proteinuria on two consecutive readings taken no less than 24 hours apart are ineligible
•Patients with QTc prolongation (defined as a QTc interval greater than or equal to 480 msecs) are ineligible
•Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring parenteral antibiotics at the time of registration), cardiac disease NYHA class III or IV, unstable angina pectoris, unstable cardiac arrhythmia or tachycardia (heart rate \>= 100 beats per minute), poorly controlled hypertension (systolic blood pressure \>= 140 mmHg or diastolic blood pressure \>= 90 mmHg)
•Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow AZD0530 tablets are excluded
•Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
•Pregnant women are excluded from this study because AZD0530 has the potential for teratogenic or abortifacient effects as shown by the gross fetal malformation and effects on embryofetal survival seen in reproductive toxicity studies in the rat
•Patients with a history of another primary malignancy within the last 5 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
•Patient who are known to be HIV-positive are ineligible because of the potential for pharmacokinetic interactions with AZD0530 and antiretroviral therapy (HAART)

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

November 1, 2006

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

August 20, 2019

Enrollment

ACTUAL participants

Conditions

Adenocarcinoma of the ColonAdenocarcinoma of the RectumRecurrent Colon CancerRecurrent Rectal CancerStage IV Colon CancerStage IV Rectal Cancer

Interventions

saracatinib

DRUG

laboratory biomarker analysis

OTHER

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Colon Cancer Liver MetastasisColon Cancer+4 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer

Inclusion Criteria

Exclusion Criteria

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