Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Cetuximab

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antineoplastic Agents, Immunological

Folate

Vitamin B9

FOLFOX 6:

* Oxaliplatin 100 mg/m² d1 concurrent with
* Leucovorin 400 mg/m², followed by
* Bolus 5FU 400 mg/m² , followed by
* Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:

FOLFIRI:

* Irinotecan 180 mg/m² day 1 concurrent with
* Leucovorin 400 mg/m² followed by
* Bolus 5FU 400 mg/m², followed by
* Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks

Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan

FOLFOX 6

FOLFIRI

Werner Scheithauer, MD

In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.

The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.

EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.

Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.

Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer

Central European Cooperative Oncology Group

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery

Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;

Combined with :

5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).

Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.

Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):

Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.

Radiation

Surgery

this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Theresa Ryan, MD

The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.

Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine.

In summary, the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.

Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer

A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer

This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).

This is the time at which 50% of patients are alive from the trial entry .

Sanofi

NYU Langone Health

treating period plus 30 days after the last protocol treatment

Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:

Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;

Combined with :

5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).

Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.

Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):

Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.

Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

This study did not reach its target accrual due to slow accrual. Small number of patients were analyzed.

Resectability After Chemoradiation

Secondary Measure was not reported. Contacted PI. No new Data available.

Median Overall Survival

Overall Study

Capecitabine

Levoleucovorin

Endothelial Growth Factors

Mitogens

Folinic Acid

Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.

Subjects will receive escalating doses of Pazopanib in combination with CapeOx. CapeOx treatment consisted of IV oxaliplatin (130 mg/m\^2) on Day 1 plus oral capecitabine (1000 mg/m\^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment was administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine was reduced to 850 mg/m\^2 twice daily.

Pazopanib is an oral inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit kinases

Pazopanib

FOLFOX 6 treatment consists of intravenous (IV) oxaliplatin (100 milligram per meter\^2\[mg/m\^2\]), and folinic acid (400 mg/m\^2), IV 5-fluorouracil bolus (400 mg/m\^2) followed by IV 5-fluorouracil (2400 to 3000 mg/m\^2) infusion over 48 hours on Day 1 of every 14-day cycle.

CapeOx treatment consists of IV oxaliplatin (130 mg/m\^2) on Day 1 plus oral capecitabine (1000 mg/m\^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment will be administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine will be reduced to 850 mg/m\^2 twice daily.

CapeOx

GSK Clinical Trials

This study will test the safety of treating colorectal cancer with a combination of drugs. The current standard treatments of FOLFOX6 or CapeOx will be give in combination with the GSK investigational drug pazopanib.

Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)

An Open-Label, Pharmacokinetic Study of the Safety and Tolerability of Pazopanib in Combination With FOLFOX 6 or CapeOx in Subjects With Colorectal Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer	NCT00286130	Metastatic Colo...	Cetuximab, Oxal... FOLFOX 6 FOLFIRI	18 Years -	Central European Cooperative Oncology Group
Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer	NCT00463840	Pancreatic Canc...	Oxaliplatin 5FU Radiation Surgery FOLFOX 6	18 Years -	NYU Langone Health
Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer	NCT00463840	Pancreatic Canc...	Oxaliplatin 5FU Radiation Surgery FOLFOX 6	18 Years -	NYU Langone Health
Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)	NCT00387387	Neoplasms, Colo...	Pazopanib FOLFOX 6 CapeOx	21 Years -	GlaxoSmithKline
Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer	NCT00286130	Metastatic Colo...	Cetuximab, Oxal... FOLFOX 6 FOLFIRI	18 Years -	Central European Cooperative Oncology Group
Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)	NCT00387387	Neoplasms, Colo...	Pazopanib FOLFOX 6 CapeOx	21 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for folfox 6

Every month we try and update this database with for folfox 6 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for folfox 6

Every month we try and update this database with for folfox 6 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for folfox 6 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.