E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with unresectable advanced or metastatic pancreatic cancer |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033609 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the feasibility and the toxicity of increasing doses of Gemcitabine given as fixed dose rate infusion of 10 mg/m2/min every 2 weeks in combination with Erlotinib. |
|
E.2.2 | Secondary objectives of the trial |
- Activity of the treatment in terms of objective response rate (partial response and complete response)
- Efficacy: progression-free and overall survival |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Histologically confirmed unresectable advanced or metastatic pancreatic adenocarcinoma
- Measurable or evaluable disease. To be considered evaluable for complete or partial response patients must have at least one measurable lesion.
- age 18-70 yrs
- PS 0-1 (ECOG scale)
- No previous chemotherapy for advanced/metastatic pancreatic carcinoma. Previous adjuvant treatment is allowed.
- Patients must have no uncontrolled concurrent serious medical illness.
- Investigations including chest x-ray, CT scan of abdomen and pelvis and other scans (as clinically indicated), have to be performed within 28 days prior to start the treatment.
- Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to start the treatment:
ANC > 1500/l
PLT > 100000/l
Creatinine < 1.5 times the ULN
Total Bilirubine < 2 times the ULN
GOT < 2 times the ULN or < 5 times in case of liver metastasis
GPT < 2 times the ULN or < 5 times in case of liver metastasis
- Written informed consent |
|
E.4 | Principal exclusion criteria |
- history of malignancies in the last 5 years
- significant history of cardiac disease, uncontrolled high blood pressure, instable angina, congestive heart failure, myocardial infarction within the last year.
- Serious active infection or serious underling medical conditions
- Known CNS metastases. CT scan of brain is not required unless there is clinical suspicion of CNS involvement
- GI tract disease resulting in an inability to take oral medication or a requirement of IV alimentation, prior surgery procedure affecting absorption, uncontrolled inflammatory GI disease
- Serious active infection or serious underlying medical conditions that would impair the ability of the patient to receive the treatment.
- Prior treatment with inhibitors of EGFR |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary
- MTD of Gemcitabine given as fixed dose rate infusion given in combination with Erlotinib
Biological
- When tumor tissue available before and after at least 4 courses of treatment: EGFR, EGFR gene copy number (FISH), p-EGFR, p-MAPK, p-Akt, p21, EGFR mutation (exons 18, 19, 21), VEGFR |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |