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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737373
• Other study ID #: FLOT65+
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2008
• Last updated: September 18, 2012
• Start date: August 2007
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: Krankenhaus Nordwest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagogastric Junction
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel
50mg/m2 qd15
• 5-Fluorouracil
2600mg/m2 qd15
• Oxaliplatin
85mg/m2 qd15
• folinic acid
200mg/m2 qd15

Locations

Country	Name	City	State
Germany	Krankenhaus Nordwest	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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 Nov;19(11):1882-7. doi: 10.1093/annonc/mdn403. Epub 2008 Jul 31. — View Citation

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. doi: 10.1200/JCO.2007.13.9378. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response (WHO criteria)		staging every 8 weeks	No