Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma (TART)
This study has been completed.
Sponsor:
Duke University
Collaborator:
Genentech
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00735306
First received: August 13, 2008
Last updated: December 1, 2011
Last verified: December 2011
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Purpose
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Avastin Drug: Tarceva Radiation: Radiation Therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Tarceva Maximum Tolerated Dose in mg [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]Tarceva maximum tolerated dose in mg
Secondary Outcome Measures:
- Number of Dose Limiting Toxicities [ Time Frame: Within 30 days of completing radiation ] [ Designated as safety issue: Yes ]
- Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]Average survival (months) from date of diagnosis to death
| Enrollment: | 12 |
| Study Start Date: | July 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Avastin, Tarceva and Radiation Therapy
|
Drug: Avastin
Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy
Other Name: bevacizumab
Drug: Tarceva
Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy
Other Name: erlotinib
Radiation: Radiation Therapy
Radiation to the pancreas Monday through Friday for 28 treatments
|
Detailed Description:
This is a phase I/II study in which up to 18 patients will be enrolled in the phase I portion and up to an additional 26 patients in the phase II portion. Patients will be treated with Tarceva (cohort specified dose), along with fixed doses of Avastin and radiation therapy.
Avastin will be given as an IV dose on days 1, 15, and 29. Tarceva will be given as a once daily by mouth. On radiation days Tarceva will be taken immediately before or after XRT.
XRT will be given to a total dose of 50.4 Gy in 28 fractions, each fraction given once daily on Monday through Friday for 5.5 weeks
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years
- Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, T1-4, N0-1, M0. Patients should have disease for which combined modality therapy is indicated.
- Performance status 0-2
- Life expectancy > 3 months
- Adequate hematologic, renal, hepatic function
- Calculated creatinine Cl > 50 mL/min
- Use of effective means of contraception in patients of child-bearing potential.
Exclusion Criteria:
- No prior therapy for pancreatic cancer
- Previous treatment with bevacizumab or erlotinib
- Evidence of duodenal invasion or gastric outlet obstruction
- Presence of bleeding diathesis or coagulopathy
- History or prior arterial thrombotic event
- Conditions leading to inadequate gastrointestinal tract absorption
- Poorly controlled diarrhea .
- Presence of baseline proteinuria or renal dysfunction (CrCl < 50 (Cockcroft-Gault equation)
- Inadequately controlled hypertension
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Clinically significant peripheral vascular disease
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Pregnant or lactating females
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to comply with study and/or follow-up procedures
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with a current PSA of <1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry.
- Comorbid conditions that would complicate safety or compliance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735306
Locations
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Duke University
Genentech
Investigators
| Principal Investigator: | Brian Czito, MD | Duke University Medical Center, Dept Radiation Oncology |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00735306 History of Changes |
| Other Study ID Numbers: | 00001597 |
| Study First Received: | August 13, 2008 |
| Results First Received: | October 14, 2011 |
| Last Updated: | December 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Locally advanced Unresectable |
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 |
Bevacizumab Erlotinib Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013