Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00684099 |
Recruitment Status :
Completed
First Posted : May 26, 2008
Last Update Posted : December 15, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Drug: Docetaxel Drug: Pemetrexed | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Docetaxel
Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
Other Name: Taxotere Drug: Pemetrexed Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
Other Name: Alimta |
- Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet [ Time Frame: 2 years ]
- Response rate for the docetaxel/pemetrexed doublet [ Time Frame: 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684099
Greece | |
University General Hospital of Alexandroupolis, Dep of Medical Oncology | |
Alexandroupolis, Greece | |
"IASO" General Hospital of Athnes, Dep of Medical Oncology | |
Athens, Greece | |
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | |
Athens, Greece | |
Air Forces Military Hospital, Dep of Medical Oncology | |
Athens, Greece | |
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | |
Athens, Greece | |
Sotiria" General Hospital, 1st Dep of Pulmonary Diseases | |
Athens, Greece | |
"Diabalkaniko" Hospital of Thessaloniki | |
Thessaloniki, Greece | |
"Theagenion" Anticancer Hospital of Thessaloniki | |
Thessaloniki, Greece |
Principal Investigator: | Vassilis Georgoulias, MD | University Hospital of Crete | |
Principal Investigator: | Athanasios Kotsakis, MD | University Hospital of Crete |
Responsible Party: | V.Georgoulias, University Hospital of Crete |
ClinicalTrials.gov Identifier: | NCT00684099 |
Other Study ID Numbers: |
CT/05.18 |
First Posted: | May 26, 2008 Key Record Dates |
Last Update Posted: | December 15, 2009 |
Last Verified: | December 2009 |
NSCLC Pemetrexed Docetaxel |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Docetaxel Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |