A Randomized, Controlled Phase III Trial of Picoplatin and Best Supportive Care (BSC) versus BSC Alone in Patients with Small Cell Lung Cancer (SCLC), Refractory or Progressive within Six Months of Completing First-Line, Platinum-Containing Chemotherapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 399

Inclusion Criteria

To be included in the study, subjects must meet all of the following criteria:
1. Histological or cytological diagnosis of SCLC (except small cell
adenocarcinoma) or combined SCLC/NSCLC defined as SCLC mixed with
squamous cell carcinoma, adenocarcinoma, or large cell carcinoma.
2. One and only 1 prior cisplatin or carboplatin-containing chemotherapy regimen
for SCLC within the scope of the NCCN Guidelines.
3. Radiologic evidence of SCLC that never responded or progressed within
90 days after completion of first-line therapy (refractory); or responded initially
to first-line therapy but progressed between 91 and 180 days after treatment was
completed (progressed within 91 to180 days).
4. CT scans of chest and abdomen (including adrenals and full extent of liver) with
contrast, preferably within 14 days prior to randomization (up to 21 days is
allowed if necessary). MRI is acceptable in the case of allergy to contrast
agents. The presence or absence of measurable disease by RECIST must be
documented from the baseline CT or MRI scan.
5. Head CT or MRI scan within 14 days prior to randomization (up to 21 days is
allowed if the study was done prior to signing of the informed consent form)
demonstrating absence of brain metastases.
6. ECOG PS 0, 1 or 2 within 3 days prior to randomization.
7. Life expectancy of at least 8 weeks within 3 days prior to randomization.
8. At least 21 days must have elapsed since the most recent prior chemotherapy
dose, with evidence of hematological recovery.
9. At least 14 days must have elapsed since the most recent prior radiotherapy dose.
10. At least 14 days must have elapsed since prior surgery except for the placement
of venous access device or bronchoscopy.
11. Subject must be recovered to = Grade 1 toxicity from all non-hematological
adverse effects of prior therapies (excluding alopecia).
12. Age 18 years or over.
13. ANC = 1.5 x 109/L.
14. Platelet count = 100 x 109/L.
15. Hemoglobin of = 90 g/L (transfusion permitted to achieve this hemoglobin).
16. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and lactate
dehydrogenase (LDH) levels = 2.5 times upper limit of normal (ULN) or
= 5 times ULN if liver involvement is present.
17. Bilirubin of = 1.5 times ULN.
18. Blood Urea Nitrogen (BUN) = 1.5 times ULN (hypovolemic subjects may be
hydrated to achieve this BUN).
19. Creatinine clearance of = 50mL/min, as calculated by the Cockcroft-Gault
formula.
20. Women of childbearing potential must have a negative pregnancy test (serum or
urine). Sexually active couples of child-bearing potential must agree to use
appropriate birth control methods during chemotherapy and for 3 months after
chemotherapy.
21. Signed informed consent.
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

Exclusion Criteria

Subjects meeting any of the following criteria must be excluded from study participation:
1. Prior radiotherapy that included = 30% of the bone marrow.
2. Pleural effusion as the only radiological evidence of SCLC.
3. Presence or history of brain or central nervous system (CNS) metastases.
4. Grade 2 or higher peripheral neuropathy.
5. Significant cardiac disease, defined as myocardial infarction within 3 months
prior to randomization, congestive heart failure classified by the New York
Heart Association as Class III or IV, uncontrolled cardiac arrhythmias, poorly controlled or unstable angina or electrocardiographic evidence of acute ischemia.
6. Serious medical or psychiatric illness that could potentially interfere with the
completion of study treatment according to this protocol, e.g., active infection,
Crohn’s disease, ulcerative colitis, etc.
7. Use of other investigational drugs within 30 days prior to randomization.
8. Breast-feeding.
9. History of any other malignancy within 5 years, with the exception of treated
non-melanoma skin cancer or carcinoma in situ of the cervix.

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

Related Trials