Pancreatic Cancer
Conditions
Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
Brief summary
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.
Detailed description
OBJECTIVES: * Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel. * Determine the objective response rate and overall survival of patients treated with these regimens. * Determine the incidence of thromboembolic events in patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15. * Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.
Interventions
DRUGrhuMAB-VEGF
DRUGdocetaxel
Sponsors
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate | 56 days |
| Overall Survival | From date of registration until the date of death, assessed up to 5 years |
| Number of Participants With Thromboembolic Events | 93 days |
Countries
United States
Participant flow
Recruitment details
Study was conducted at Fox Chase Cancer Center between October 2004 and December 20006.
Participants by arm
| Arm | Count |
|---|---|
| rhuMAB-VEGF rhuMAB-VEGF : | 16 |
| rhuMAB-VEGF and Docetaxel rhuMAB-VEGF :
docetaxel : | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 5 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 11 Participants | 17 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 16 | 16 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 13 / 16 | 15 / 16 |
Outcome results
Primary
Progression-free Survival
Time frame: 4 months
Population: The study was stopped according to the early stopping rule for futility. All patients who entered the study have died.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| rhuMAB-VEGF | Progression-free Survival | 43 days |
| rhuMAB-VEGF and Docetaxel | Progression-free Survival | 48 days |
Secondary
Number of Participants With Thromboembolic Events
Time frame: 93 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rhuMAB-VEGF | Number of Participants With Thromboembolic Events | 3 participants |
| rhuMAB-VEGF and Docetaxel | Number of Participants With Thromboembolic Events | 2 participants |
Secondary
Objective Response Rate
Time frame: 56 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rhuMAB-VEGF | Objective Response Rate | 0 participants |
| rhuMAB-VEGF and Docetaxel | Objective Response Rate | 0 participants |
Secondary
Overall Survival
Time frame: From date of registration until the date of death, assessed up to 5 years
Population: The study was stopped according to the early stopping rule for futility. None of the patients survived.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| rhuMAB-VEGF | Overall Survival | 165 days |
| rhuMAB-VEGF and Docetaxel | Overall Survival | 125 days |