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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 January 2013 |
Main ID: |
EUCTR2007-003751-37-IT |
Date of registration:
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11/03/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A phase II, Dose-Escalation to Rash Trial of Erlotinib (Tarceva) plus Gemcitabine in Patients With Metastatic Pancreatic Cancer. - RACHEL
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Scientific title:
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A phase II, Dose-Escalation to Rash Trial of Erlotinib (Tarceva) plus Gemcitabine in Patients With Metastatic Pancreatic Cancer. - RACHEL |
Date of first enrolment:
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08/04/2008 |
Target sample size:
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560 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003751-37 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: - same IMP used at different dosage
Number of treatment arms in the trial: 1
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Phase:
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Countries of recruitment
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Austria
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Belgium
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France
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Germany
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Greece
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Italy
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Lithuania
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion Criteria for initial 4 weeks run-in period. Disease specific inclusion criteria: 1. Histologically or cytologically confirmed pancreatic cancer (adenocarcinoma) with measurable or non-measurable metastatic disease (stage IV); 2. Life expectancy of ≥ 8 weeks. General inclusion criteria: 3. Age ≥ 18 years; 4. ECOG performance status of 0 - 1 (see section 5.3.2); 5. Able to comply with the protocol; 6. Written (signed) Informed Consent to participate in the study; 7. Adequate hematological function: ANC ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and Hb ≥ 9 g/dL; 8. PT-INR ≤ 1.5 and PTT ≤ 1.5 x ULN within 7 days prior to start of study treatment; 9. Adequate liver function: serum (total) bilirubin ≤ 1.5 x ULN, SGOT (AST) and SGPT (ALT) < 2.0 x ULN; 10. Albumin > 3.0 g/dL; 11. Adequate renal function: serum creatinine < 1.5 ULN ;12. For all females of childbearing potential a negative pregnancy test must be obtained within 7 days before start of treatment. Inclusion criteria for randomization between day 29 and 35 (after 4 weeks run-in period): 1. Completion of 4 weeks run-in period, without clinical evidence of disease progression, as per investigators opinion; 2. Patients who have not developed rash grade ≥ 2 during the 4 weeks run-in period; 3.Patients who have not developed any other toxicity leading to dose adjustments / discontinuation (for either gemcitabine or erlotinib) during the 4 weeks run-in period. Patients who during the run-in period have had only one gemcitabine related dose reduction (75% of full dose) for hematological toxicity, are eligible for randomization provided they are stable and tolerating the 75% of full dose and no further reductions are anticipated; 4. ECOG performance status of 0 - 1 (see section 5.3.2); 5. Adequate hematological function: ANC ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and Hb ≥ 9 g/dL; 6. Adequate liver function: serum (total) bilirubin ≤ 1.5 x ULN, SGOT (AST) and SGPT (ALT) < 2.0 x ULN; 7. Albumin > 3.0 g/dL ; Et al... Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Disease specific exclusion criteria: 1. Local (Stage Ia to IIb) pancreatic cancer and locally advanced (stage III) pancreatic cancer. (Patients relapsing with metastatic disease, after initial diagnosis with local or locally advanced disease can be enrolled into this study) 2. Prior chemotherapy or treatment with another systemic anti-cancer agent for locally advanced-unresectable or metastatic pancreatic cancer 3. Less than (or equal to) 6 months since last adjuvant chemotherapy. Patient must have recovered from all treatment related toxicities prior to 4 weeks run-in period and must have documented evidence of disease progression (metastatic) following adjuvant chemotherapy 4. Prior treatment with an investigational or marketed agent which acts on the EGFR axis. EGFR inhibitors include (but are not limited to) erlotinib, gefitinib or other anti-EGFR or EGF monoclonal antibody therapy or dual TKI inhibitors 5. Prior adjuvant radiotherapy for pancreatic cancer, except for patients with progressive lesions outside the radiation port who completed the radiotherapy at least 6 months prior to study entry 6. Any other malignancies within the last 5 years before study start, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer 7. Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 4 weeks before study start) in case of clinical suspicion or evidence of brain metastases General exclusion criteria: 8. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (≤ 6 months before study start), myocardial infarction (≤ 6 months before study start), unstable angina, NYHA ≥ grade 2 CHF, arrhythmia requiring medication, hepatic, renal or metabolic disease, metabolic dysfunction), physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications 9. Patients who have had any major surgery within 2 weeks prior to study start 10. Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended) 11. Patients unable to take oral medication, requiring intravenous alimentation, who have mal-absorption syndrome or any other conditions affecting gastrointestinal absorption, or who have active peptic ulcer disease 12. Pregnant or lactating females 13. Men and women of childbearing potential (<2 years after last menstruation) not using effective means of contraception (e.g. oral contraceptives, intrauterine contraceptive device, sexual abstinence, or surgically sterile), effective meaning failure rate < 1%/year 14. Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study 15. Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection. 16. Hypersensitivity to erlotinib or to gemcitabine or to any of the excipients or to compounds with similar chemical or biologic composition
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Metastatic Pancreatic Cancer MedDRA version: 14.1
Level: LLT
Classification code 10033605
Term: Pancreatic cancer metastatic
System Organ Class: 100000004864
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Intervention(s)
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Trade Name: TARCEVA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: erlotinib CAS Number: 183321-74-6 Current Sponsor code: Ro 50-8231 Concentration unit: mg milligram(s) Concentration number: 25-
Trade Name: TARCEVA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: erlotinib CAS Number: 183321-74-6 Current Sponsor code: Ro 50-8231 Concentration unit: mg milligram(s) Concentration number: 100-
Trade Name: TARCEVA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: erlotinib CAS Number: 183321-74-6 Current Sponsor code: Ro 50-8231 Concentration unit: mg milligram(s) Concentration number: 150-
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Primary Outcome(s)
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Secondary Objective: - To evaluate the safety and tolerability of increased doses of erlotinib in combination with gemcitabine. - To evaluate if increasing the dose of erlotinib increases the incidence of grade ≥2 rash vs those who continue on 100 mg erlotinib. - To compare PFS, response and disease control rates between patients with increased dose of erlotinib vs those who continue on 100 mg erlotinib. - To make a non randomized comparison of efficacy and safety between patients who do develop vs those who do not develop grade 2 or higher rash during the first 4 weeks of therapy. - To correlate biomarkers (EGFR expression, EGFR gene copy number, K-ras mutations, EGFR Intron 1 polymorphisms) with outcomes and response to treatment (ORR, PFS, OS).
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Main Objective: To determine, in patients who do not develop any rash, or develop only grade 1 rash, within 4 weeks of start of treatment with gemcitabine + erlotinib, if overall survival can be improved by increasing the dose of erlotinib compared to patients who continue on 100 mg erlotinib.
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Primary end point(s): Overall survival
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Secondary ID(s)
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2007-003751-37-FR
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BO21128
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Source(s) of Monetary Support
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Results
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Results available:
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