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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Jeroen Bosch Ziekenhuis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier:
NCT00686985
First received: May 27, 2008
Last updated: May 29, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: Carboplatin, docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jeroen Bosch Ziekenhuis:

Primary Outcome Measures:
  • Response rate [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression; Response duration; Survival; Safety profile [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: September 2007
Estimated Study Completion Date: July 2010
Arms Assigned Interventions
Experimental: A Drug: Carboplatin, docetaxel
Carboplatin AUC 5, Docetaxel 75 mg/m2, q 3 weeks, 4-6 cycles, 12-18 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr. B. Biesma, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier: NCT00686985     History of Changes
Other Study ID Numbers: DOCAR study
Study First Received: May 27, 2008
Last Updated: May 29, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on October 29, 2014