Docetaxel - Carboplatin As Second Line Treatment in Patients with Small Cell Lung Cancer

NCT00686985 | Completed Phase 2

• 1 other identifier: DOCAR study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Keywords

Docetaxel; Carboplatin; chemotherapy; relapse SCLC

Outcome Measures

Primary Outcomes (1)

• Response rate

  2 yrs

Secondary Outcomes (1)

• Time to progression; Response duration; Survival; Safety profile

  2 yrs

Study Arms (1)

A

EXPERIMENTAL

Drug: Carboplatin, docetaxel

Interventions

Carboplatin, docetaxel DRUG

Carboplatin AUC 5, Docetaxel 75 mg/m2, q 3 weeks, 4-6 cycles, 12-18 weeks

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. B. Biesma: lead

Study Sites (1)

B. Biesma

's-Hertogenbosch, North Brabant, 5211NL, Netherlands

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; 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

• B Biesma, Dr.

  Jeroen Bosch Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Pulmonologist

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: September 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 20, 2024

Record last verified: 2024-03

Locations

NL (1)