Small Cell Lung CancerPhase 2DOCARNCT00686985
Docetaxel - Carboplatin As Second Line Treatment in Patients with Small Cell Lung Cancer
A Phase 2 study testing Carboplatin, docetaxel in people with Small Cell Lung Cancer, run by Dr. B. Biesma at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Carboplatin, docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2007to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Carboplatin, docetaxel
- Keywords
- Docetaxel, Carboplatin, chemotherapy, relapse SCLC
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin, docetaxelDrug
Carboplatin AUC 5, Docetaxel 75 mg/m2, q 3 weeks, 4-6 cycles, 12-18 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Carboplatin, docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 2 yrs
Secondary outcomes (1)
Time to progression; Response duration; Survival; Safety profile
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startSep 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. B. Biesma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. B. Biesma, Jeroen Bosch Ziekenhuis
- Investigators
- B Biesma, Dr., Principal investigator, Jeroen Bosch Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686985
- Sponsor's protocol ID
- DOCAR study
- Acronym
- DOCAR
- Status last verified
- Mar 2024
- First submitted
- 27 May 2008
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Docetaxel - Carboplatin As Second Line Treatment in Patients with Refractory or Relapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00686985
- Acronym / sponsor ID
- DOCAR / DOCAR study
- Conditions
- Small Cell Lung Cancer
- Keywords
- Docetaxel, Carboplatin, chemotherapy, relapse SCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. B. BiesmaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Carboplatin, docetaxel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carboplatin, docetaxelCarboplatin AUC 5, Docetaxel 75 mg/m2, q 3 weeks, 4-6 cycles, 12-18 weeks | Drug | A |
Primary outcome
Response rate
Time frame: 2 yrs
1 secondary outcome
Time to progression; Response duration; Survival; Safety profile
Time frame: 2 yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B Biesma, Dr. principal investigator
Jeroen Bosch Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, docetaxel in people with Small Cell Lung Cancer, run by Dr. B. Biesma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 2 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.