Clinical trial · Interventional
Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer
NCT01175733CI-TRIAL-00026520VectibixcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to investigate whether the addition of panitumumab to radiotherapy plus gemcitabine will increase the number of patients who are alive and progression free at 7 months.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panitumumab | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Panitumumab
- interventionNames
- Drug: Panitumumab
Primary outcomes (3)
- measure
- Phase I: the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab.
- timeFrame
- 43 days
- description
- During the phase I part of the study, we have planned to study four dose levels of panitumumab if no MTD is being derived before the final dose level. Patients will be enrolled in cohorts of 3 per dose level. If there are no dose-limiting toxicities (DLTs) experienced by the first 3 patients in a cohort during the first 43 days after the first study treatment, additional patients will be entered in the next dose level. At the final dose level recommended for the phase II study a minimum of 6 patients will be treated.
- measure
- Phase II: the proportion of patients that is alive and progression-free at 7 months.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histological or cytological confirmed pancreatic cancer.
* Not eligible for curative resection.
* No distant metastases present.
* Previously untreated with chemotherapy and anti-cancer biologicals for current malignancy.
* No other current malignant disease, except for basal cell carcinoma of the skin.
* Measurable or evaluable disease as defined by RECIST 1.1 criteria.
* Performance status 0-2 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale.
* Age ≥ 18 years.
* Adequate haematological and biological functions:
* Bone marrow function:
1. Neutrophils ≥ 1.5 x 109/L
2. Platelets ≥ 100 x 109/L
3. Hb ≥ 6 mmol/L
* Hepatic function:
1. AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN)
2. Bilirubin ≤ 1.5 times institutional ULN
* Renal function:
eGFR \>50ml/min
• Metabolic Function:
1. Magnesium ≥ lower limit of normal
2. Calcium ≥ lower limit of normal.
* No imminent bowel obstruction.
* No active bleeding.
* No uncontrolled infection.
* Patients with reproductive potential must use effective contraception. Female patients must have a negative pregnancy test.
* Signed informed consent.
Exclusion Criteria:
* Participation in another therapeutic clinical study within 30 days of enrollment or during this clinical study.
* No adequate radiation therapy possible: based on the opinion of the radiation oncologist when radiation therapy cannot be performed because radiation field is too large (PTV volume too large or OAR too high)
* History of allergic reactions to gemcitabine or antibody treatment.
* Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection, uncontrolled hypertension).
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 1 year before enrolment/randomization
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
* Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance.
* Pregnant or breastfeeding women.
* Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment.
* Known positive status for HIV and/or hepatitis B or C.
* Any reason why, in the investigator's opinion, the patient should not participate in the study.
* Drug or alcohol abuse.References
Publications (0)
Data not yet available
No reference posted for this study.