Clinical trial · Interventional
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
NCT00066677CI-TRIAL-00050493terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stopped accordining to early stopping rule for futility
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells. PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| rhuMAB-VEGF | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- rhuMAB-VEGF
- description
- bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.
- interventionNames
- Drug: rhuMAB-VEGF
- type
- EXPERIMENTAL
- label
- rhuMAB-VEGF and Docetaxel
- description
- rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle. Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.
- interventionNames
- Drug: rhuMAB-VEGF
- Drug: docetaxel
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * Metastatic disease * Unidimensionally measurable disease outside of the pancreas * At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Must have received 1, and only 1, prior gemcitabine-containing regimen for metastatic disease unless disease has recurred within 6 months after treatment with neoadjuvant or adjuvant gemcitabine-containing therapy * No brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL (transfusion allowed) * No bleeding diathesis or coagulopathy Hepatic * Bilirubin no greater than upper limit of normal (ULN) * AST and ALT no greater than 1.5 times ULN * INR no greater than ULN * PTT no greater than ULN Renal * Creatinine no greater than 2.0 mg/dL * No clinically significant renal impairment * Urine protein:creatinine ratio ≥ 1.0 Cardiovascular * No prior myocardial infarction * No prior stroke * No clinically significant cardiovascular disease * No uncontrolled hypertension (i.e., blood pressure greater than 160/110 mm Hg on medication) * No unstable angina * No New York Heart Association class II-IV congestive heart failure * No serious cardiac dysrhythmia requiring medication * No peripheral vascular disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history or evidence of CNS disease (e.g, primary brain tumor or seizures not controlled with standard medical therapy) * No other medical condition that would preclude study participation * No psychiatric condition that would preclude study participation * No other prior or concurrent malignancy that would preclude study participation * No significant traumatic injury within the past 28 days * No serious, nonhealing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic granulocyte or platelet growth factors Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * More than 7 days since prior fine needle aspirations or core biopsies * More than 28 days since prior surgery (except closed biopsy or access port placement) * More than 28 days since prior open biopsy * No concurrent surgery Other * More than 4 weeks since prior experimental drug study participation * More than 4 weeks since prior investigational drugs * No other concurrent experimental drug study participation
References
Publications (1)
- RESULTAstsaturov IA, Meropol NJ, Alpaugh RK, Burtness BA, Cheng JD, McLaughlin S, Rogatko A, Xu Z, Watson JC, Weiner LM, Cohen SJ. Phase II and coagulation cascade biomarker study of bevacizumab with or without docetaxel in patients with previously treated metastatic pancreatic adenocarcinoma. Am J Clin Oncol. 2011 Feb;34(1):70-5. doi: 10.1097/COC.0b013e3181d2734a. PMID 20458210