Paclitaxel, Carboplatin, and Dimethylxanthenone Acetic Acid in Treating Patients With Extensive-Stage Small Cell Lung Cancer

NCT01057342 | Completed Phase 2

• 5 other identifiers: SAKK 15/08SWS-SAKK-15-08EUDRACT-2009-016960-34EU-21001NOVARTIS-CASA404ACCH01T
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 12

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dimethylxanthenone acetic acid may stop the growth of small cell lung cancer by blocking blood flow to the tumor. Giving paclitaxel and carboplatin together with dimethylxanthenone acetic acid may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and carboplatin together with dimethylxanthenone acetic acid and to see how well they work in treating patients with extensive-stage small cell lung cancer.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate

  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.

  at 24 weeks (6 months)

Secondary Outcomes (5)

• Adverse events by NCI CTCAE v3.0

  until 30 days after trial therapy end

• Best objective response OR complete or partial response according to RECIST 1.1

  whilst receiving the trial therapy

• Time to progression

  Defined as the time from registration until documented Small-cell Lung Cancer (SCLC) progression or death as a result of SCLC.

• Overall survival

  Time from registration until death as a result of any cause.

• One-year survival rate

  at 1 year

Study Arms (1)

Paclitaxel, Carboplatin, ASA404

EXPERIMENTAL

Drug: carboplatin; Drug: paclitaxel; Drug: vadimezan

Interventions

carboplatin DRUG

AUC 6 i.v. given after paclitaxel as the second treatment on day 1 of each 3-week cycle.

Also known as: Paraplatin

Paclitaxel, Carboplatin, ASA404

paclitaxel DRUG

175 mg/m2 i.v. first treatment on day 1 of each 3-week cycle.

Also known as: Abraxane Taxol

Paclitaxel, Carboplatin, ASA404

vadimezan DRUG

1800 mg/m2 i.v. following the administration of paclitaxel and carboplatin on day 1 of each 3-week cycle

Also known as: ASA404

Paclitaxel, Carboplatin, ASA404

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 weeks) * 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 participation * 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 following: * 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 \[polyoxyethylated castor oil\]) PRIOR CONCURRENT THERAPY: * 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 irradiation * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (12)

Saint Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Onkologie Schaffhausen

Schaffhausen, CH-8200, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8032, Switzerland

Location

Related Publications (1)

• Fruh M, Cathomas R, Siano M, Tscherry G, Zippelius A, Mamot C, Erdmann A, Krasniqi F, Rauch D, Simcock M, Kuttel E, Fustier P, Pless M; Swiss Group for Clinical Cancer Research. Carboplatin and paclitaxel plus ASA404 as first-line chemotherapy for extensive-stage small-cell lung cancer: a multicenter single arm phase II trial (SAKK 15/08). Clin Lung Cancer. 2013 Jan;14(1):34-9. doi: 10.1016/j.cllc.2012.04.001. Epub 2012 May 24.

  PMID: 22633220 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Carboplatin; Paclitaxel; vadimezan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Martin Frueh, MD

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

• Miklos Pless, MD

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Oliver Gautschi, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2012
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

CH (12)