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Carboplatin and Paclitaxel Plus ASA404 as First Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): A Phase II Trial

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Carboplatin and Paclitaxel Plus ASA404 as First Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): A Phase II Trial



- To assess the 24-week (6 months) progression-free survival of patients with extensive
stage small cell lung cancer treated with paclitaxel, carboplatin, and
dimethylxanthenone acetic acid.


- To assess efficacy and safety of this regimen in these patients.

- To evaluate predictive molecular markers for gene expression analyses, serum
proteomics, and pharmacogenomics. (exploratory)

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and
dimethylxanthenone acetic acid IV over 20 minutes on day 1. Treatment repeats every 21 days
for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples may be collected periodically for predictive molecular markers for
gene expression analysis, plasma proteomics, and pharmacogenomics.

After completion of study treatment, patients are followed every 6 months.

Inclusion Criteria


- Histologically (preferred) or cytologically confirmed small-cell lung carcinoma
(SCLC) by surgical biopsy, brushing, washing, OR core needle aspiration (sputum
cytology alone not acceptable)

- Extensive stage or stage IV disease, including patients with malignant pleural
or pericardial effusion

- No pleural effusion that causes ≥ CTC grade 2 dyspnea

- Not suitable for potentially curative combined-modality treatment for this disease

- Measurable or non-measurable disease

- No CNS metastases


- WHO performance status 0-2

- Hemoglobin ≥ 10.0 g/dL

- Absolute neutrophils ≥ 2.0 x 10^9/L (without the use of growth factors)

- Platelet count ≥ 100 x 10^9/L

- Bilirubin ≤ 1.5 x the upper limit of normal (ULN)

- ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)

- Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)

- Creatinine clearance ≥ 45 mL/min

- INR ≤ 1.5

- Magnesium, potassium, and calcium (corrected for albumin) normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 12 months after
completion of study therapy

- No recent hemoptysis associated with SCLC (> 1 teaspoon in a single episode within 4

- No other malignancy within the past 5 years except for nonmelanoma skin cancer or
cervical cancer in situ

- Must not have a history of any of the following conditions:

- Myocardial infarction within the past 12 months

- Uncontrolled hypertension (systolic BP > 160 mm Hg and/or diastolic BP > 90 mm
Hg) or poor compliance with anti-hypertensive regimen

- Sustained ventricular tachycardia

- Ventricular fibrillation or Torsades de Pointes

- Long QT syndrome

- QTc of > 450 msec

- NYHA class III or IV congestive heart failure

- Unstable or poorly controlled angina pectoris, including Prinzmetal variant
angina pectoris

- Right bundle branch block and left anterior hemiblock (bifascicular block)

- Bradycardia (defined as heart rate < 50 beats per minute)

- Cardiac arrhythmias (i.e., symptomatic, but may not require medications) CTCAE
grade ≥ 2

- No significant neurologic or psychiatric disorder that would compromise study

- No peripheral sensory neuropathy with functional impairment ≥ CTC grade 2 (regardless
of cause)

- No concurrent severe and/or uncontrolled medical disease, including any of the

- Uncontrolled diabetes

- Chronic renal disease

- Chronic liver disease

- Confirmed diagnosis of HIV infection

- Active uncontrolled infection

- No serious underlying medical condition, in the judgment of the investigator, that
would impair the patient's ability to participate in the trial

- No known hypersensitivity to study drugs or to any other component of the study drugs
(taxanes or other drugs formulated in Cremophor EL [polyoxyethylated castor oil])


- Recovered from all prior therapy

- No prior systemic chemotherapy, immunotherapy, or biologic anti-cancer therapy

- More than 2 weeks since prior and no concurrent radiotherapy

- Localized palliative radiotherapy to symptomatic bone metastases allowed

- More than 2 weeks since minor surgery

- Insertion of a vascular access device allowed

- More than 3 weeks since prior dimethylxanthenone acetic acid for prophylactic cranial

- More than 4 weeks since major surgery (defined by the use of general anesthesia)

- At least 30 days since prior and no other concurrent investigational drugs or
anti-cancer therapy

- No treatment in a clinical trial within 30 days prior to trial entry

- No concurrent therapy with a risk of causing Torsades de Pointes

- No concurrent drugs that would be contraindicated for use with study drugs

- No factors with the potential to prolong QT interval

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate

Outcome Description:

The status of progression free survival at 24 weeks (+/- 2 weeks) from trial registration will be assessed. A PFS event is defined as (whichever occurs first): Relapse or progression assessed according to the RECIST 1.1 criteria (Appendix 1) Death of any cause.

Outcome Time Frame:

at 24 weeks (6 months)

Safety Issue:


Principal Investigator

Martin Frueh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital St. Gallen


Switzerland: Swissmedic

Study ID:

SAKK 15/08



Start Date:

January 2010

Completion Date:

July 2012

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma