Non Small Cell Lung CancerPhase 1/2NCT00684099
Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing Docetaxel and Pemetrexed in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
Trial summary
This trial will determine the maximum tolerated dose the recommended phase II dose and the efficacy of this combination in locally advanced or metastatic NSCLC patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Docetaxel and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesGreece
- Study dates
- May 2006to May 2009
- Phase
- Phase 1/2
- 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
- Histologically confirmed inoperable (stage IIIB-IV) NSCLC. A block of Formaline Fixed Parafine Embedded tissue representative for the primary diagnosis should be available for genomic analysis (phase II part)
- Written informed consent
- Prior chemotherapy with platinum compounds in association with or without taxanes (phase I part)
- Previously untreated with docetaxel and pemetrexed (phase II part)
- Bidimensionally, non-irradiated measurable disease (according to RECIST criteria) (phase II)
- Age ≥18 years
Show all 13Show fewer
- World Health Organization (WHO) performance status (PS) 0-2
- Life expectancy of at least 12 weeks
- Serum bilirubin less than 1.5 times the upper normal limit (UNL)
- AST and ALT less than 2.5 times the UNL in the absence of demonstrable liver metastases, or less than 5 times the UNL in the presence of liver metastases.
- Serum creatinine less than 1.5 times the UNL
- Neutrophil count more than 1.5x 109 /L
- Platelet count more than 100x 109 /L
Who cannot join
- Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
- Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- Patients with unstable central nervous system metastases
- Malnutrition (loss of ≥ 20% of the original body weight)
- Performance status: 4
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
Air Forces Military Hospital, Dep of Medical Oncology
Athens
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens
Sotiria" General Hospital, 1st Dep of Pulmonary Diseases
Athens
"Diabalkaniko" Hospital of Thessaloniki
Thessaloniki
"Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki
About this study
Official title: A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC
This trial will determine the maximum tolerated dose the recommended phase II dose and the efficacy of this combination in locally advanced or metastatic NSCLC patients
Read the detailed description
Docetaxel as single-agent therapy (100 mg/m2 and 75 mg/m2, every 3 weeks) produces response rates of 26% to 54%. Docetaxel has proven superior compared to best supportive care (BSC) in chemotherapy-naïve as well as in platinum pretreated patients. In addition, docetaxel is active in cisplatin refractory or resistant patients, producing responses ranging from 18% to 25%, implying a lack of cross-resistance between docetaxel and cisplatin, probably due to their different mechanisms of action. Furthermore, docetaxel is associated with significant prolongation of survival when administered as second line therapy, in pretreated patients with advanced NSCLC. Phase II studies of pemetrexed in previously untreated patients with NSCLC have demonstrated single agent response rates of 17% to 23%. A phase II study of pemetrexed in patients with advanced NSCLC, who had progressed during or within 3 months of completing first-line chemotherapy, demonstrated a response rate of 8.9% and median survival time of 5.7 months. Multivariate analysis established an association between an increased risk of severe pemetrexed toxicity and elevated homocysteine (folate and/or B12 vitamin deficiency marker) levels. Since December 1999, all pemetrexed-treated patients are required to receive folic acid and Vitamin B12. A recently reported phase III study compared pemetrexed with docetaxel as 2nd line therapy in patients with advanced NSCLC. Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Docetaxel, Pemetrexed
- Keywords
- NSCLC, Pemetrexed, Docetaxel
- 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.
DocetaxelDrug
Also called Taxotere
Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
PemetrexedDrug
Also called Alimta
Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Docetaxel; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet
Measured: 2 years
Secondary outcomes (1)
Response rate for the docetaxel/pemetrexed doublet
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 posted26 May 2008 (estimated)
- Study startMay 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Vassilis Georgoulias, MD, Principal investigator, University Hospital of CreteAthanasios Kotsakis, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684099
- Sponsor's protocol ID
- CT/05.18
- Status last verified
- Dec 2009
- First submitted
- 22 May 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kotsakis A, Agelaki S, Vardakis N, Stathopoulos G, Vamvakas L, Kalykaki A, Kentepozidis N, Kontopodis E, Sfakiotaki G, Mavroudis D, Georgoulias V. A dose-escalation study of pemetrexed and docetaxel in non-small-cell lung cancer. Cancer Chemother Pharmacol. 2011 Aug;68(2):415-22. doi: 10.1007/s00280-010-1508-5. Epub 2010 Nov 11.
PubMed 21069335
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT00684099
- Acronym / sponsor ID
- CT/05.18
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, Pemetrexed, Docetaxel
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- May 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 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.
This trial will determine the maximum tolerated dose the recommended phase II dose and the efficacy of this combination in locally advanced or metastatic NSCLC patients
Detailed description
Docetaxel as single-agent therapy (100 mg/m2 and 75 mg/m2, every 3 weeks) produces response rates of 26% to 54%. Docetaxel has proven superior compared to best supportive care (BSC) in chemotherapy-naïve as well as in platinum pretreated patients. In addition, docetaxel is active in cisplatin refractory or resistant patients, producing responses ranging from 18% to 25%, implying a lack of cross-resistance between docetaxel and cisplatin, probably due to their different mechanisms of action. Furthermore, docetaxel is associated with significant prolongation of survival when administered as second line therapy, in pretreated patients with advanced NSCLC. Phase II studies of pemetrexed in previously untreated patients with NSCLC have demonstrated single agent response rates of 17% to 23%. A phase II study of pemetrexed in patients with advanced NSCLC, who had progressed during or within 3 months of completing first-line chemotherapy, demonstrated a response rate of 8.9% and median survival time of 5.7 months. Multivariate analysis established an association between an increased risk of severe pemetrexed toxicity and elevated homocysteine (folate and/or B12 vitamin deficiency marker) levels. Since December 1999, all pemetrexed-treated patients are required to receive folic acid and Vitamin B12. A recently reported phase III study compared pemetrexed with docetaxel as 2nd line therapy in patients with advanced NSCLC. Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel, Drug: Pemetrexed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed inoperable (stage IIIB-IV) NSCLC. A block of Formaline Fixed Parafine Embedded tissue representative for the primary diagnosis should be available for genomic analysis (phase II part)
- Written informed consent
- Prior chemotherapy with platinum compounds in association with or without taxanes (phase I part)
- Previously untreated with docetaxel and pemetrexed (phase II part)
- Bidimensionally, non-irradiated measurable disease (according to RECIST criteria) (phase II)
Key exclusion criteria (8 listed)
- Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
- Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- Patients with unstable central nervous system metastases
- Malnutrition (loss of ≥ 20% of the original body weight)
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 |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles | Drug | 1 |
| PemetrexedAlso: AlimtaPemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles | Drug | 1 |
Primary outcome
Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet
Time frame: 2 years
1 secondary outcome
Response rate for the docetaxel/pemetrexed doublet
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 15 Dec 2009.
- Derived from this study: PubMed 21069335Kotsakis A, Agelaki S, Vardakis N, Stathopoulos G, Vamvakas L, Kalykaki A, Kentepozidis N, Kontopodis E, Sfakiotaki G, Mavroudis D, Georgoulias V. A dose-escalation study of pemetrexed and docetaxel in non-small-cell lung cancer. Cancer Chemother Pharmacol. 2011 Aug;68(2):415-22. doi: 10.1007/s00280-010-1508-5. Epub 2010 Nov 11.
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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.
Vassilis Georgoulias, MD principal investigator
University Hospital of Crete
Athanasios Kotsakis, MD principal investigator
University Hospital of Crete
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel and Pemetrexed in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 8 sites in Greece.
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 13 inclusion and 8 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 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00684099, which also lists 1 linked publication.
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 15 Dec 2009.