Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy

NCT00349089 | Completed Phase 2 DMC

• 2 other identifiers: TREAT2005-004840-30
• Study Type: interventional
• Target: 132
• Locations: 3 countries
• Sites: 14

Brief Summary

The purpose of this randomized phase II trial is to determine the clinical feasibility - in terms of patients without dose limiting toxicities or premature treatment withdrawal or death - of the combination of Cisplatin and Pemetrexed and of the combination of Cisplatin and Vinorelbine. The combination of Cisplatin / Pemetrexed is assumed to be distinctly less toxic than Vinorelbine / Cisplatin.

Conditions

Non Small Cell Lung Cancer

Keywords

Non-small cell lung cancer; adjuvant therapy; clinical feasibility rate

Outcome Measures

Primary Outcomes (1)

• To determine the clinical feasibility rate of 4 cycles of adjuvant chemotherapy with Pemetrexed and Cisplatin vs. Vinorelbine and Cisplatin

  4 month

Secondary Outcomes (8)

• To determine and compare the drug delivery between both treatment arms

  4 month

• To determine the Time to Treatment Failure (TTTF)

  3 years

• To determine the Distant Metastases Free Survival (DMFS)

  3 years

• To determine the Local Relapse Free Survival (LRFS)

  3 years

• To determine the Overall Survival (OS)

  3 years

Study Arms (2)

1

ACTIVE COMPARATOR

Cisplatin/Vinorelbine

Drug: Cisplatin; Drug: Vinorelbine

2

EXPERIMENTAL

Cisplatin/Pemetrexed

Drug: Pemetrexed; Drug: Cisplatin

Interventions

Pemetrexed DRUG

Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22

2

Cisplatin DRUG

Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22 Comparator: Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29 Cisplatin 50 mg/m2 d1, 8; q d29

1; 2

Vinorelbine DRUG

Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29

1

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed diagnosis of non-small cell lung cancer (NSCLC), pathologic stage IB, IIA, IIB or T3N1 (without need for further radiotherapy).
• Complete tumor resection without detectable residual tumor including negative margins (R0) and systematic intraoperative dissection of mediastinal lymph nodes of course lymph node dissection has to comprise all lymph node levels to be removed with standard right or left sided resection. The dissection has to assure the removal of mediastinal lymph nodes more than 1,5 cm on the preoperative CT scan.
• Study drug administration should only be administered to patients with full recovery after surgery and is to begin on d28 to d42 postoperatively
• The following histological tumor types are eligible:
• Squamous Cell Carcinoma
• Adenocarcinoma (including adenocarcinomas with bronchioloalveolar differentiation)
• Large Cell Carcinoma (excluding tumors with slight areas of small cell carcinoma)
• Mixed Cell Carcinoma without small cell fraction
• Provision of informed consent according to local regulatory requirements for participation in the study
• Age ≥ 18 years; \< 75 Years
• Karnofsky Performance Status 80% or ECOG 1
• Adequate hematological laboratory parameters
• Hemoglobin 10 g/dl
• ANC 1500/µl
• Platelets 100000/µl

You may not qualify if:

• Presence of a Pancoast tumor
• Involvement of N2/N3 lymph nodes
• Distant metastases
• The following histological tumor types are excluded
• Pure bronchioloalveolar carcinoma
• Mixed cell carcinoma with small cell fractions
• Large Cell Carcinoma with areas of small cell carcinoma
• Pregnancy or lactation period
• Radio- and/or chemotherapy within the last five years
• Concurrent administration of any other antitumor therapy
• Patients who are not compliant with vitamin (folic acid and vitamin B12) intake or to whom administration is not possible
• Hypersensitivity to Pemetrexed or to any of the excipients of Alimta®
• Hypersensitivity to Cisplatin or to any other platinum compound
• Hypersensitivity to Vinorelbin or to any other vinca-alkaloid
• Patient has previously completed or withdrawn from this study or any other study with the respective medication in this study

Sponsors & Collaborators

• Thoraxklinik-Heidelberg gGmbH: lead

Study Sites (14)

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Department of Pulmonology (Respiratory Tumor Unit), University Hospital Gasthuisberg, Catholic University Leuven, Belgium.

Leuven, 3000, Belgium

Location

Helios-Klinikum Emil von Behring

Berlin, 14109, Germany

Location

Klinikum Bremen-Ost

Bremen, 28325, Germany

Location

Westdeutsches Tumorzentrum

Essen, 45122, Germany

Location

Department of Hematology and Oncology, University of Göttingen

Göttingen, 37075, Germany

Location

Lungenzentrum Großhansdorf

Großhansdorf, 22927, Germany

Location

Clinic for thoracic diseases at the University of Heidelberg

Heidelberg, 69120, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Klinik Löwenstein

Löwenstein, 74245, Germany

Location

University of München

München, Germany

Location

Oldenburg Hospital

Oldenburg, Germany

Location

Dr. Horst Schmidt Klinik

Wiesbaden, 65199, Germany

Location

Centre Hospitalier du Luxembourg

Luxembourg, L-1210, Luxembourg

Location

Related Publications (6)

• Winton T, Livingston R, Johnson D, Rigas J, Johnston M, Butts C, Cormier Y, Goss G, Inculet R, Vallieres E, Fry W, Bethune D, Ayoub J, Ding K, Seymour L, Graham B, Tsao MS, Gandara D, Kesler K, Demmy T, Shepherd F; National Cancer Institute of Canada Clinical Trials Group; National Cancer Institute of the United States Intergroup JBR.10 Trial Investigators. Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. N Engl J Med. 2005 Jun 23;352(25):2589-97. doi: 10.1056/NEJMoa043623.

  PMID: 15972865 BACKGROUND

• Alam N, Shepherd FA, Winton T, Graham B, Johnson D, Livingston R, Rigas J, Whitehead M, Ding K, Seymour L. Compliance with post-operative adjuvant chemotherapy in non-small cell lung cancer. An analysis of National Cancer Institute of Canada and intergroup trial JBR.10 and a review of the literature. Lung Cancer. 2005 Mar;47(3):385-94. doi: 10.1016/j.lungcan.2004.08.016.

  PMID: 15713522 BACKGROUND

• Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60. doi: 10.1056/NEJMoa031644.

  PMID: 14736927 BACKGROUND

• Strauss G, Herndon J, Maddaus MA, et al. Randomized clinical trial of adjuvant chemotherapy with Paclitaxel and Carboplatin following resection in stage I B non-small cell lung cancer (NSCLC): Report of Cancer and Leukaemia Group B (CALGB) protocol 9633. Proc Am Soc Clin Oncol 22: 621 (# 7019)2004

  BACKGROUND

• Douillard J, Rosell R, Delena M, et al. ANITA: Phase III adjuvant Vinorelbine and Cisplatin versus observation in completely resected (stage I-III) non-small lung cancer patients: Final results after 70-month median follow up. Proc Am Soc Clin Oncol 23: 624 (# 7013) 2005

  BACKGROUND

• Kreuter M, Vansteenkiste J, Griesinger F, Hoffmann H, Dienemann H, De Leyn P, Thomas M. Trial on refinement of early stage non-small cell lung cancer. Adjuvant chemotherapy with pemetrexed and cisplatin versus vinorelbine and cisplatin: the TREAT protocol. BMC Cancer. 2007 May 8;7:77. doi: 10.1186/1471-2407-7-77.

  PMID: 17488518 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Vinorelbine

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)

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Michael Thomas, Prof. Dr.

  Clinic for thoracic diseases at the University of Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

• Michael Kreuter, Dr.

  Clinic for thoracic diseases at the University of Heidelberg, Germany

  STUDY CHAIR

• Johan Vansteenkiste, Prof. Dr.

  Department of Pulmonology (Respiratory Tumor Unit), University Hospital Gasthuisberg, Catholic University Leuven, Belgium

  STUDY CHAIR

• Frank Griesinger, Prof. Dr.

  Department of Hematology and Oncology, Oldenburg, Germany.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2006
• First Posted: July 6, 2006
• Study Start: September 26, 2006
• Primary Completion: April 14, 2014
• Study Completion: April 14, 2014
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

BE (2); LU (1); DE (11)