A randomized phase 2 study of LY2181308 in combination with docetaxel versus docetaxel in hormone refractory prostate cancer - N/A
- Conditions
- Hormone Refractory Prostate Cancer (HRPC)
- Registration Number
- EUCTR2007-004907-37-DE
- Lead Sponsor
- Eli Lilly and Company limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 150
Patients may be included in the study only if they meet all of the following criteria:
[1]Histologically or cytologically confirmed adenocarcinoma of the prostate, which is metastatic and cannot be resectable.
[2]Hormone refractory prostate cancer defined as progression under prior hormonal treatment with LHRH analogues or orchiectomy and anti-androgens, given either together or consecutively; and eligible to receive docetaxel and prednisone as first line chemotherapy treatment.
[3]Progressive disease is defined as PSA progression documented by 2 consecutive increased PSA values compared to a previous reference value. A total of 3 PSA measurements are required prior to registration into the trial. Each PSA level should be taken weekly to obtain the required 3 levels with the first PSA level used as the reference value. After a minimum of one week from the PSA reference value, a second PSA level should be collected to verify PSA increase. A third PSA value (i.e, the confirmation of elevated PSA) should occur a minimum of one week from the second PSA value. Because of potential fluctuation in PSA levels, the following process should be followed: If the third PSA value is decreased from the second, then a fourth PSA will be drawn within 7 days to confirm the increase from the initial reference value. Such cases will be discussed in detail with the Lilly clinical physician (Bubley et al. 1999).
[4]All patients must be withdrawn from anti-androgens such as Flutamide, Bicalutamide, or Nilutamide. If a patient has been on anti-androgens prior to start of study enrollment, they have to demonstrate a continued elevation of PSA for at least 4 weeks after withdraw of anti-androgen therapy (or 6 weeks for bicalutamide or depending on which anti-androgen they have been on) prior to registration on study.
[5]PSA greater than or equal to 5 ng/mL (Hybritech or equivalent) within 1 week prior to randomization.
[6] All patients are eligible regardless of measurability of disease by RECIST. Note: A patient may be eligible based on PSA response when other symptoms are present, such as pain or pleural effusion, etc. as defined by non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. However, only those patients with at least one unidimensionally measurable lesion meeting RECIST (RECIST; Therasse et al. 2000 ) criteria at baseline will be followed for objective response.
[7]Age =18 years.
[8]ECOG status 0-2 (see Protocol Attachment JACR.6).
[9]Castrate level of testosterone (=0.5 ng/mL).
[10]Patients with medical castration with LHRH analogue must continue LHRH analogue.
[11]Adequate venous access.
[12]Adequate hematological functions as assessed by Hgb =10 g/dL; WBC =3.5 109/l, ANC =1.5 109/l , and platelets =100 109/l.
[13]Adequate liver function as assessed by bilirubin less than or equal to upper limit of the normal range (UNL) and AST =1.5 x UNL and ALT =1.5 x UNL.
[14]Adequate renal function as assessed by serum creatinine =1.5 xULN.
[15]Activated partial thromboplastin time (aPTT) =1.5xUNL (for those receiving warfarin, prothrombin time (PT) must be =1.5xUNL [or international normalized ratio (INR)=1.3]).
[16]Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Patients will be excluded from the study if they meet any of the following criteria:
[18]Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[19]Have previously completed or withdrawn from this study or any other study investigating LY2181308 sodium.
[20]Have known hypersensitivity to docetaxel or taxane therapy.
[21]Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis.
[22]Evidence of painful and/or destructive bone metastases for which radiation therapy, biophosphonates or bone-seeking radionucleides are considered necessary by the treating physician. Other bone metastases are allowed. If patients are stable on biphosphonates for 2 months or more, they may be enrolled if there is no other sign of progression.
[23]Had prior treatment with bone-seeking radionucleides (e.g., Rhenium, Samarium or Strontium) in the last 6 weeks prior to study enrollment, or radiotherapy involving more than 25% of marrow producing area. Radiotherapy less than 25% of marrow producing area should be stopped at least 14 days prior to study enrollment.
[24] Had treatment with estramustine, ketoconazole, finesteride, intravesical Bacillus Calmette-Guerin (BCG) application or any other non-approved substances with known impact on PSA within 30 days prior to study enrollment.
[25]Had prior hormonal manipulation with PC-SPES or other herbal remedies that contain hormonal products that can interfere with the conduct of the study within the last 6 weeks prior to entry on study.
[26]Concurrent treatment with other anti-cancer drugs .
[27]Known hypersensitivity to oligonucleotides or any component of the formulation.
[28]CVA or transient ischemic attack, deep venous thrombosis or myocardial infarction attacks within the past 6 months prior to entry on study.
(29): Active infection or known HIV.
[30]History of interstitial pneumonitis or pulmonary fibrosis.
[31]Patients with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
[32]Patients with serious preexisting medical conditions including, but not limited to unstable angina, pulmonary embolism, uncontrolled hypertension and unmanageable bleeding risk (at the investigator’s discretion).
[33]Pre-existing neuropathy.
[34]Patients with a second primary malignancy that could affect interpretation of the results. NOTE: Patients with adequately treated carcinoma of the skin (excluding melanoma) and patients with a prior history of malignancy who have been disease-free for more than 5 years are eligible.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method