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Docetaxel - Carboplatin as Second Line Treatment in Patients With Small Cell Lung Cancer (DOCAR)

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ClinicalTrials.gov Identifier: NCT00686985
Recruitment Status : Unknown
Verified May 2008 by Jeroen Bosch Ziekenhuis.
Recruitment status was:  Recruiting
First Posted : May 30, 2008
Last Update Posted : May 30, 2008
Sponsor:
Information provided by:
Jeroen Bosch Ziekenhuis

Brief Summary:
Phase II studies with docetaxel in first line - and second line treatment of SCLC demonstrated that docetaxel is an active agent in these patient groups. Therefore docetaxel seems suitable for evaluation in combination with other cytotoxic drugs active in this disease. A phase II study in previously untreated patients with SCLC shows that the combination docetaxel and cisplatin/carboplatin is an active and well tolerated regimen in extensive SCLC.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Carboplatin, docetaxel Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Docetaxel - Carboplatin as Second Line Treatment in Patients With Refractory or Relapsed Small Cell Lung Cancer
Study Start Date : September 2007
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: A Drug: Carboplatin, docetaxel
Carboplatin AUC 5, Docetaxel 75 mg/m2, q 3 weeks, 4-6 cycles, 12-18 weeks




Primary Outcome Measures :
  1. Response rate [ Time Frame: 2 yrs ]

Secondary Outcome Measures :
  1. Time to progression; Response duration; Survival; Safety profile [ Time Frame: 2 yrs ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven SCLC at the first diagnosis
  • Refractory or relapsed SCLC
  • Measurable disease according to RECIST criteria
  • There must be a minimum of 2 weeks between the end of prior radiotherapy and study entry. (No more than 30% of available bone marrow should have been irradiated as recommended by the RTOG).
  • Patients must have fully recovered from toxic effects of previous antitumor therapy.
  • Age > 18 years.
  • WHO performance status 0- 2 (Appendix II).
  • Hb > 6.0 mmol/L,

    • Neutrophils > 1.5 x 109/L,
    • Platelets > 100 x 109/L·
  • Total bilirubin < the upper-normal limits of the institutional normal values.
  • ALAT (SGPT), ASAT (SGOT) < 2.5 times the upper-normal limits of the institutional normal values.
  • Alkaline Phosphatase < 5 times the upper-normal limits of the institutional normal values. If AP > 2.5 x ULN then ALAT and ASAT must be <1.5 x ULN, otherwise, the patient is not eligible
  • Creatinine < 140 mmol/L; or creatinine clearance according to Cockcroft formula >50 ml/min·
  • Signed informed consent prior to beginning protocol specific procedures

Exclusion Criteria:

  • More than one line of chemotherapy for metastatic disease
  • Treatment with a platinum compound during the last 3 months before randomisation
  • Pregnant or lactating women or women of childbearing potential not adhering to adequate anticonceptive measures
  • Evidence of (other) active invasive malignancy other than non-melanoma skin cancer.
  • Clinical evidence CNS metastases.
  • Symptomatic peripheral neuropathy > grade 2 according (NCI CTC, Appendix III)Definite contraindications for the use of corticosteroids
  • Concurrent treatment with other experimental drugs.
  • Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
  • Concurrent treatment with any other cytotoxic anti-cancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686985


Contacts
Contact: B Biesma, Dr. 31-073-699-2615 b.biesma@jbz.nl
Contact: F.M.N.H. Schramel, Dr. 31-030-609-3459 f.schramel@antonius.net

Locations
Netherlands
B. Biesma Recruiting
's-Hertogenbosch, Brabant, Netherlands, 5211NL
Contact: B. Biesma, Dr.    31-073-699-2615    b.biesma@jbz.nl   
Contact: F. Schramel, Dr.    31-0609-9111    f.schramel@antonius.net   
Sub-Investigator: H van der Heijden, Dr.         
Sub-Investigator: J.N.H. Timmer - Bonte, Dr.         
Sub-Investigator: H Smit, Dr.         
Sub-Investigator: H.J.M. Groen, Prof. Dr.         
Sponsors and Collaborators
Jeroen Bosch Ziekenhuis
Investigators
Principal Investigator: B Biesma, Dr. Jeroen Bosch Ziekenhuis

Responsible Party: Dr. B. Biesma, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier: NCT00686985     History of Changes
Other Study ID Numbers: DOCAR study
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Keywords provided by Jeroen Bosch Ziekenhuis:
Docetaxel
Carboplatin
chemotherapy
relapse SCLC

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Carboplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action