Oxaliplatin and 5-Fluorouracil With or Without Docetaxel in Elderly Patients (>65 y) With Stomach and Esophagus Cancer - Full Text View

Purpose

In this trial, FLOT will be evaluated as therapy option for elderly patients (>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.

Condition	Intervention	Phase
Gastric Cancer Adenocarcinoma of the Esophagogastric Junction	Drug: Docetaxel Drug: 5-Fluorouracil Drug: Oxaliplatin Drug: folinic acid	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Randomised Phase II Trial on the Therapy of Advanced Gastric Cancer or Adenocarcinoma of the Esophagogastric Junction in Patients Older Than 65 Years With Specific Regard of Quality of Life and Pharmacogenetic Risk Profile

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Stomach Cancer

Drug Information available for: Fluorouracil Folic acid Leucovorin calcium Oxaliplatin Levoleucovorin Docetaxel

U.S. FDA Resources

Further study details as provided by Krankenhaus Nordwest:

Primary Outcome Measures:

response (WHO criteria) [ Time Frame: staging every 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	143
Study Start Date:	August 2007
Study Completion Date:	March 2011
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 FLOT	Drug: Docetaxel 50mg/m2 qd15 Drug: 5-Fluorouracil 2600mg/m2 qd15 Drug: Oxaliplatin 85mg/m2 qd15 Drug: folinic acid 200mg/m2 qd15
Active Comparator: 2 FLO	Drug: 5-Fluorouracil 2600mg/m2 qd15 Drug: Oxaliplatin 85mg/m2 qd15 Drug: folinic acid 200mg/m2 qd15

Detailed Description:

Patients with locally advanced, potentially operable or metastatic gastric cancer or adenocarcinoma of the esophagogastric junction without prior therapy in the palliative setting are treated with:

Arm A: FLO
Arm B: FLOT

max. 12 cycles

Evaluation of quality of life by standard forms at baseline and then every 2 months until progress of disease. Pharmacogenetic analyses will be done to evaluate a risk profile for platin-based therapies. 140 patients will be treated (70 per arm)

primary endpoint:

Response Rate

secondary endpoints:

Prospective Validation of a pharmacogenetic risk profile for patients with advanced GC under first-line therapy with platin/docetaxel
Evaluation of quality of life
safety and tolerability
progression free survival (PFS), time to treatment failure (TTF), overall survival (OS)

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction
no prior chemotherapy in metastatic state
adequate blood and biochemistry parameters

Exclusion Criteria:

hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel
KHK, cardiomyopathy or cardiac insufficiency
malignancy <5 years ago
brain metastases
severe internal disease or inadequate blood and biochemistry parameters

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737373

Locations

Germany
Krankenhaus Nordwest
Frankfurt, Germany, 60488

Sponsors and Collaborators

Krankenhaus Nordwest

Investigators

Study Chair:

Salah Al-Batran, MD

Krankenhaus Nordwest

More Information

Publications:

Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, Rethwisch V, Seipelt G, Homann N, Wilhelm G, Schuch G, Stoehlmacher J, Derigs HG, Hegewisch-Becker S, Grossmann J, Pauligk C, Atmaca A, Bokemeyer C, Knuth A, Jäger E; Arbeitsgemeinschaft Internistische Onkologie. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008 Mar 20;26(9):1435-42.

Al-Batran SE, Hartmann JT, Hofheinz R, Homann N, Rethwisch V, Probst S, Stoehlmacher J, Clemens MR, Mahlberg R, Fritz M, Seipelt G, Sievert M, Pauligk C, Atmaca A, Jäger E. Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol. 2008 Jul 31; [Epub ahead of print]

Al-Batran SE, Atmaca A, Hegewisch-Becker S, Jaeger D, Hahnfeld S, Rummel MJ, Seipelt G, Rost A, Orth J, Knuth A, Jaeger E. Phase II trial of biweekly infusional fluorouracil, folinic acid, and oxaliplatin in patients with advanced gastric cancer. J Clin Oncol. 2004 Feb 15;22(4):658-63.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Al-Batran SE, Pauligk C, Homann N, Hartmann JT, Moehler M, Probst S, Rethwisch V, Stoehlmacher-Williams J, Prasnikar N, Hollerbach S, Bokemeyer C, Mahlberg R, Hofheinz RD, Luley K, Kullmann F, Jäger E. The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: a randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+). Eur J Cancer. 2013 Mar;49(4):835-42. doi: 10.1016/j.ejca.2012.09.025. Epub 2012 Oct 11.

Responsible Party:	Krankenhaus Nordwest
ClinicalTrials.gov Identifier:	NCT00737373 History of Changes
Other Study ID Numbers:	FLOT65+
Study First Received:	August 18, 2008
Last Updated:	September 18, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Adenocarcinoma
Adenocarcinoma, Mucinous
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

Head and Neck Neoplasms
Esophageal Diseases
Fluorouracil
Oxaliplatin
Docetaxel
Leucovorin
Folic Acid
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 16, 2013