Protocol H3E-MC-JMHO(a)A Randomized Phase 3 Trial of ALIMTA (Pemetrexed)and Carboplatin versus Etoposide and Carboplatin inExtensive-Stage Small Cell Lung Cancer - ND
- Conditions
- Previously untreated patients with ED-SCLCMedDRA version: 9.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stage
- Registration Number
- EUCTR2006-001173-14-IT
- Lead Sponsor
- ELI LILLY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1770
[1] Histological or cytological diagnosis of ED-SCLC, including
malignant pleural effusion.
[2] Performance status of 0 to 2 on the ECOG performance status
schedule (Oken et al. 1982). (See Protocol Attachment JMHO.3)
[3] No prior systemic chemotherapy, immunotherapy, or biological
therapy for SCLC.
[4] Prior radiation therapy allowed to <25% of the bone marrow. Patients
who have received prior radiation to the whole pelvis or chest for the
treatment of SCLC are not eligible. Prior radiotherapy must be
completed at least 2 weeks before study enrollment. Patients must
have recovered from the acute toxic effects of the treatment prior to
study enrollment.
[5] At least one unidimensionally measurable lesion meeting Response
Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000).
A measurable lesion is defined as a lesion that can be accurately
measured in at least one dimension and is >=20 mm with conventional
techniques or is >=10 mm with spiral computed tomography (CT) scan
(longest diameter to be recorded).
Positron emission tomography (PET) scans and ultrasounds may not
be used for lesion measurements (see Protocol Attachment JMHO.5).
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[6] Adequate organ function including the following:
Adequate bone marrow reserve: absolute neutrophil (segmented and
bands) count (ANC) >=1.5 x 109/L, platelets >=100 x 109/L, and
hemoglobin >=9 g/dL.
Hepatic: bilirubin <=1.5 times the upper limit of normal (ULN), alkaline
phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase
(AST) <=3.0 x ULN (AP, AST, and ALT <=5 x ULN is acceptable if liver
has tumor involvement).
Renal: calculated creatinine clearance (CrCl) >=45 mL/min based on the
standard Cockcroft and Gault formula (Cockcroft and Gault 1976). (See
Protocol Attachment JMHO.6)
[7] Estimated life expectancy of at least 12 weeks.
[8] For women: Must be surgically sterile, post-menopausal, or compliant
with a medically approved contraceptive regimen (for example,
intrauterine device [IUD], birth control pills, or barrier device) during
and for 6 months after the treatment period; must have a negative
serum or urine pregnancy test within 7 days before study enrollment,
and must not be breast-feeding.
For men: Must be surgically sterile or compliant with a contraceptive
regimen during and for 6 months after the treatment period.
[9] Patient compliance and geographic proximity that allow adequate
follow up.
[10] Patient or his/her legal representative must sign an informed consent
document.
[11] Patients must be at least 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
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
Patients will be excluded from the study if they meet any of the following criteria:
[12] 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.
[13] Have previously participated in a study involving pemetrexed.
[14] Have a mixed histological diagnosis of SCLC and NSCLC.
[15] Have a serious concomitant systemic disorder that, in the opinion of
the investigator, would compromise the patient's ability to adhere to
the protocol.
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[16] Have an active infection (>=38.5?C and/or receiving intravenous
antibiotic therapy).
[17] Have a serious cardiac condition, such as myocardial infarction within
6 months, angina, or heart disease as defined by the New York Heart
Association Class III or IV (Protocol Attachment JMHO.8).
[18] Have had recent (within 30 days of study treatment) or concurrent
yellow fever vaccination.
[19] Have had a prior malignancy other than SCLC, carcinoma in situ of
the cervix, or nonmelanoma skin cancer, unless that prior malignancy
was diagnosed and definitively treated at least 5 years previously with
no subsequent evidence of recurrence. Patients with a history of low
grade (Gleason score <=6) localized prostate cancer will be eligible
even if diagnosed less than 5 years previously.
[20] Symptomatic central nervous system (CNS) metastases and
asymptomatic CNS metastases requiring concurrent corticosteroid
therapy. Treated stable CNS metastases are allowed; the patient must
be stable after radiotherapy for >=2 weeks and off of corticosteroids for
>=1 week.
[21] Presence of clinically significant third-space fluid collections, for
example, ascites or pleural effusions that cannot be controlled by
drainage or other procedures prior to study entry.
[22] Significant weight loss (that is, >=10%) over the 6 week period prior to
study entry.
[23] Concurrent administration of any other antitumor therapy.
[24] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory
agents, other than an aspirin dose <=1.3 grams per day, for a 5-day
period (8-day period for long-acting agents, such as piroxicam).
[25] Inability or unwillingness to take folic acid or vitamin B12
supplementation.
[26] Inability to take corticosteroids.
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