Non-Small-Cell Lung CarcinomaPhase 2NCT01048645
Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing ATRA in people with Non-Small-Cell Lung Carcinoma, run by National Institute of Cancerología at 1 site in Mexico.
Trial summary
Purpose: This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- ATRA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2007to Nov 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage III B and IV NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No prior cytotoxic chemotherapy for NSCLC
- Age ≥18 years, adequate laboratory measurements
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Life expectancy of >12 weeks.
Who cannot join
- Patients who had received prior chemotherapy
- Patients with other comorbid conditions
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Cancerología
Mexico City, Mexico City, 14080
About this study
Official title: Randomized Phase II Trial: Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
Purpose:
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2) as a response biomarker.
Read more
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
Read the detailed description
Purpose:
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2 ) as a response biomarker.
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- ATRA, PLACEBO
- Keywords
- All-trans retinoic acid, non-small cell lung cancer, retinoic acid receptor beta, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATRADrug
Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin
PLACEBOOther
Patients were randomized to receive or placebo (P/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin
| Study group | Role | What they receive |
|---|---|---|
| P/PC arm | Placebo comparator | Patients were assigned to receive placebo (P/PC) 1 week prior to treatment until completing two cycles Receives: Other: PLACEBO |
| RA/PC arm | Experimental | Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two cycles Receives: Drug: ATRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point was Response rate (RR) and Progression-free survival (PFS), as well as identifying whether expression of RAR-beta2 is a response biomarker.
Measured: 2 years
Secondary outcomes (1)
Evaluate the efficiency and safety of low doses of ATRA in patients with advanced NSCLC who receive first-line CT.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startSep 2007
- Primary completionDec 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Collaborators
- Instituto Nacional de Enfermedades Respiratorias
- Investigators
- Oscar Arrieta, M.D., Principal investigator, National Institute of Cancerología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048645
- Sponsor's protocol ID
- ICC/302/07
- Status last verified
- Jan 2010
- First submitted
- 30 Dec 2009
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial: Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01048645
- Acronym / sponsor ID
- ICC/302/07
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- All-trans retinoic acid, non-small cell lung cancer, retinoic acid receptor beta, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- National Institute of CancerologíaOther government
- Collaborators
- Instituto Nacional de Enfermedades Respiratorias
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 13 Jan 2010 (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.
Purpose:
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2) as a response biomarker.
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
Detailed description
Purpose:
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2 ) as a response biomarker.
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P/PC arm | Placebo comparator | Other: PLACEBOPatients were assigned to receive placebo (P/PC) 1 week prior to treatment until completing two cycles |
| RA/PC arm | Experimental | Drug: ATRAPatients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two cycles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage III B and IV NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No prior cytotoxic chemotherapy for NSCLC
- Age ≥18 years, adequate laboratory measurements
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
Key exclusion criteria (2 listed)
- Patients who had received prior chemotherapy
- Patients with other comorbid conditions
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 |
|---|---|---|
| ATRAPatients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin | Drug | RA/PC arm |
| PLACEBOPatients were randomized to receive or placebo (P/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin | Other | P/PC arm |
Primary outcome
The primary end-point was Response rate (RR) and Progression-free survival (PFS), as well as identifying whether expression of RAR-beta2 is a response biomarker.
Time frame: 2 years
1 secondary outcome
Evaluate the efficiency and safety of low doses of ATRA in patients with advanced NSCLC who receive first-line CT.
Time frame: 2 years
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 13 Jan 2010.
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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.
Oscar Arrieta, M.D. principal investigator
National Institute of Cancerología
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 ATRA in people with Non-Small-Cell Lung Carcinoma, run by National Institute of Cancerología at 1 site in Mexico.
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 6 inclusion and 2 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 13 Jan 2010. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
The primary end-point was Response rate (RR) and Progression-free survival (PFS), as well as identifying whether expression of RAR-beta2 is a response biomarker. (time frame: 2 years). 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 13 Jan 2010.