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

May 29, 2008 updated by: Jeroen Bosch Ziekenhuis

A Phase II Study of Docetaxel - Carboplatin as Second Line Treatment in Patients With Refractory or Relapsed Small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background:

Small cell lung cancer (SCLC) is diagnosed in approximately 15 % of all the lung cancer cases. SCLC is recognized by its rapid tumor growth, with a high chemo- and radio sensitivity, and by its high metastasizing potential. Patients with extensive-stage disease have a 5-year survival rate of 1% to 2%.

Almost 2/3 of the patients have already extensive disease (ED) upon diagnosis.The recommended treatment of ED-SCLC is systemic chemotherapy, considered to be the standard first line treatment option in all patients with SCLC regardless of performance status and age. World-wide, the most commonly used regimen for 1st line treatment is the combination of cisplatin-etoposide, while in the Netherlands the cyclophosphamide, doxorubicin and etoposide regimen is widely used.Survival outcome with these regimens appear similar.

Unfortunately, relapses occur in all patients and responses to second-line chemotherapy have proven to be of short term. Until recently, there were no registered drugs for treatment of relapsing SCLC. 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. Until now no studies have been performed with a combination of docetaxel and platinum in this group of previously treated SCLC patients.

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.

Study objectives:

To evaluate the anti-tumor activity of a docetaxel/carboplatin regimen in patients with refractory or relapsed SCLC. Furthermore to asses the safety profile of the docetaxel/carboplatin combination.

Trial design:

This study will be a open label non-randomized study conducted in patients with refractory or relapsed SCLC. It is a phase II study with 50 patients.

Docetaxel infusion 75 mg/m2, carboplatin AUC = 6 mg/ml·min day 1, every 21 days for 4-6 cycles.

Population:

Patients with histologically or cytologically proven SCLC at the first diagnosis with refractory or relapsed SCLC after first line treatment. Signed informed consent. Age > 18 years. WHO ps 0,1 or 2.

Endpoints:

Primary endpoint: response rate. Secondary endpoint(s): time to progression, response duration, safety profile and survival.

Stress and risks for the patient:

Hospital visits and tests are not different from the standard treatment. Stress due to adverse events is not essential higher estimated. Special risks are not expected. Frequently medical examination and control of laboratory results will be done. Detailed instruction will be given about what do to in case of serious toxicity.

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Brabant
      • 's-Hertogenbosch, Brabant, Netherlands, 5211NL
        • Recruiting
        • B. Biesma
        • Contact:
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 2 yrs
2 yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression; Response duration; Survival; Safety profile
Time Frame: 2 yrs
2 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeroen Bosch Ziekenhuis

Investigators

  • Principal Investigator: B Biesma, Dr., Jeroen Bosch Ziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Estimate)

May 30, 2008

Last Update Submitted That Met QC Criteria

May 29, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOCAR study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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