Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00735917
First received: August 14, 2008
Last updated: January 14, 2013
Last verified: September 2012
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Purpose
This phase II trial is studying how well saracatinib works in treating patients with previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer |
Drug: saracatinib Other: pharmacogenomic studies Other: pharmacological study Other: laboratory biomarker analysis Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Proportion of patients alive at 6 months [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]If patients are lost to follow-up prior to the time required for the applicable primary endpoint, we will consider reporting the final point estimate of the primary endpoint via the method of Kaplan and Meier (1958) which accounts for the censoring of such data at the date of last contact (last known alive). Otherwise, ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Secondary Outcome Measures:
- Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Survival is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958). Special attention will be paid to any registered patient who dies early (i.e., within 60 days) of initiating their treatment.
- Confirmed tumor response (complete [CR] or partial response [PR]) [ Time Frame: Evaluated using the first 6 courses of treatment ] [ Designated as safety issue: No ]A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
- Duration of response [ Time Frame: From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years ] [ Designated as safety issue: No ]
- Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 2 years ] [ Designated as safety issue: No ]Progression will be evaluated in this study using the new international criteria proposed by the revised RECIST guideline (version 1.1).
- Time to treatment failure [ Time Frame: Time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 2 years ] [ Designated as safety issue: No ]
- Correlation between baseline tumor markers and response [ Time Frame: At baseline to up to 2 years ] [ Designated as safety issue: No ]Logistic regression modeling will be used to assess the relationship between baseline tumor markers and response
- Correlation between baseline tumor markers and survival [ Time Frame: At baseline to up to 2 years ] [ Designated as safety issue: No ]The prognostic capability of these baseline tumor markers will be explored via Cox proportional hazards regression models (Cox, 1972) for overall survival data.
- Correlation between baseline tumor markers and time-to-progression [ Time Frame: At baseline to up to 2 years ] [ Designated as safety issue: No ]The prognostic capability of these baseline tumor markers will be explored via Cox proportional hazards regression models (Cox, 1972) for time-to-progression data.
- Correlation between baseline tumor markers and [ Time Frame: At baseline to up to 2 years ] [ Designated as safety issue: Yes ]Logistic regression modeling will be used to assess the relationship between baseline tumor markers and adverse events.
- Dynamic changes in tumor markers from baseline to post-treatment [ Time Frame: At baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
- Changes in tumor measurements [ Time Frame: At baseline and after 2 weeks of treatment ] [ Designated as safety issue: No ]PET/computed tomography (CT) scans will be used to see if changes in the tumor measurements at 2 weeks post-treatment predict survival and response (after 8 weeks) as assessed by RECIST.
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2008 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Drug: saracatinib
Given PO
Other Name: AZD0530
Other: pharmacogenomic studies
Optional correlative studies
Other Name: Pharmacogenomic Study
Other: pharmacological study
Optional correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Procedure: positron emission tomography
Optional correlative studies
Other Names:
Radiation: fludeoxyglucose F 18
Optional correlative studies
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530 (saracatinib).
II. To determine the adverse events of this drug in these patients.
SECONDARY OBJECTIVES:
I. To evaluate the response rate in patients treated with this drug. II. To evaluate the overall survival of patients treated with this drug. III. To explore the pharmacodynamic effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and positron emission tomography (PET) scans in a subset of patients.
OUTLINE:
Patients receive saracatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
- Received ≥ 1 prior chemotherapy regimen, preferably gemcitabine hydrochloride-based
Biomarker screening portion of study:
- For subjects without archival tissue available (core biopsy or resection specimen; fine-needle aspirate samples only are not sufficient), must be willing to undergo a fresh needle-core biopsy of a safely biopsiable metastasis
- No known brain metastases
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
- White blood cell (WBC) ≥ 3,000/mm³
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Total bilirubin < 1.5 times upper normal limit (ULN) (patients may have been shunted in order to achieve normal bilirubin level)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 times ULN (< 5 times ULN for patients with liver metastases)
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Urine protein < 1,000 mg
- Urine protein: creatinine ratio ≤ 1.0
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Asymptomatic human immunodeficiency virus (HIV) allowed
- Willingness to undergo 2 tumor biopsies
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
- No prolonged QTc interval (i.e., ≥ 480 msec)
- No other significant electrocardiogram (ECG) abnormalities
- No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 150 mm Hg or diastolic BP ≥ 90 mm Hg)
No concurrent cardiac dysfunction including, but not limited to, any of the following:
- History of ischemic heart disease
- Myocardial infarction
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs ability to swallow AZD0530 tablets
No uncontrolled concurrent illness including, but not limited to any of the following:
- Ongoing or active infection
- Psychiatric illness or social situations that would limit compliance with study requirements
- No other malignancy within the past 5 years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Recovered from all prior therapy (< grade 2) (excluding alopecia) administered within the past 4 weeks
- At least 3 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)
- At least 4 weeks since prior radiotherapy
- More than 7 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4)-active agents
- No ongoing adverse events (excluding alopecia) due to chemotherapy or radiotherapy given more than 4 weeks prior to study
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent low molecular weight heparin or full-dose coumadin allowed
- Concurrent therapeutic hematopoietic growth factors allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735917
Locations
| United States, Arizona | |
| Mayo Clinic in Arizona | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Florida | |
| Mayo Clinic in Florida | |
| Jacksonville, Florida, United States, 32224-9980 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Wells Messersmith | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00735917 History of Changes |
| Obsolete Identifiers: | NCT01647035 |
| Other Study ID Numbers: | NCI-2009-00194, MC0547, CDR0000610063, N01CM62205 |
| Study First Received: | August 14, 2008 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013