Clinical trial · Interventional
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Gemcitabine, Bevacizumab and Erlotinib
- description
- single-arm, no masking
- interventionNames
- Drug: Bevacizumab
- Drug: Erlotinib
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Time to Tumor Progression
- timeFrame
- all patients will be followed for a minimum of 4 months
- description
- Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas * ECOG Performance Status 0-2 * 18 years of age or older * Radiographically measurable disease * Expected survival of at least 4 months * Creatinine of \</= 2.0 * Adequate hepatic function * Adequate hematopoietic function * Use of effective means of contraception in subjects of child-bearing potential Exclusion Criteria: * Warfarin anticoagulation * Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor * Coexistent malignant disease * Current or recent (within 4 weeks) participation in a clinical trial * Pregnancy * Documented invasion of adjacent organs or major blood vessels * Blood pressure of \> 150/100mmHg * Unstable angina * NYHA Grade II or greater congestive heart failure * History of myocardial infarction or stroke within 6 months * Clinically significant peripheral vascular disease * Evidence of bleeding diathesis of coagulopathy * Presence of CNS or brain metastases * Major surgical procedure, open biopsy, or significant traumatic event within 28 days * Minor surgical procedures, fine needle aspirations or core biopsies within 7 days * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months * Serious non-healing wound, ulcer or bone fracture
References
Publications (0)
Data not yet available