Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)

NCT00684099 | Completed Phase 1

• 1 other identifier: CT/05.18
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; Pemetrexed; Docetaxel

Outcome Measures

Primary Outcomes (1)

• Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet

  2 years

Secondary Outcomes (1)

• Response rate for the docetaxel/pemetrexed doublet

  2 years

Study Arms (1)

1

EXPERIMENTAL

Drug: Docetaxel; Drug: Pemetrexed

Interventions

Docetaxel DRUG

Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles

Also known as: Taxotere

1

Pemetrexed DRUG

Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles

Also known as: Alimta

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (8)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athnes, Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

Athens, Greece

Location

Sotiria" General Hospital, 1st Dep of Pulmonary Diseases

Athens, Greece

Location

"Diabalkaniko" Hospital of Thessaloniki

Thessaloniki, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

Related Publications (1)

• 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.

  PMID: 21069335 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Pemetrexed

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Vassilis Georgoulias, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

• Athanasios Kotsakis, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: May 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 15, 2009

Record last verified: 2009-12

Locations

GR (8)