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Safety Study of Combination Chemotherapy in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220649
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 17, 2009
Information provided by:
St. Luke's-Roosevelt Hospital Center

Brief Summary:
The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or adenocarcinoma of the pancreas.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: gemcitabine; irinotecan; leucovorin; 5-fluorouracil; oxaliplatin Phase 1

Detailed Description:
Pancreatic cancer is a major health problem in the United States and other developed nations. Approximately thirty thousand cases of adenocarcinoma of the exocrine pancreas are diagnosed in the United States each year. The majority of these tumors are unresectable at the time of diagnosis. Unresectable and metastatic pancreatic cancer is often resistant to treatment with response rates of less than 10% and median survival times of less than six months associated with single agent chemotherapy. As of July 2003, gemcitabine remains the standard of care palliative chemotherapy for patients with locally advanced or metastatic pancreatic cancer. This drug has modest clinical activity. In a phase III randomized controlled trial, 126 patients with advanced symptomatic pancreatic cancer were randomized to receive either gemcitabine 1000 mg/m2 weekly x 7 followed by a week of rest and then weekly x 3 every 4 weeks thereafter or fluorouracil 600 mg/m2 once weekly. The primary endpoint was a score of clinical benefit response (CBR) derived from a composite of pain, performance status, and weight. CBR was experienced by 24% of the gemcitabine treated patients compared with 5% of 5-FU treated patients. The median survival durations were 5.65 and 4.41 months for gemcitabine-treated and 5-FU-treated patients, respectively. The one year survival was 18% for patients treated with gemcitabine compared to 2% for patients treated with 5-FU. The effectiveness of gemcitabine may be improved by altering the standard infusion schedule to a fixed dose rate. Gemcitabine requires intracellular phosphorylation to form active di- and triphosphates, which is dose rate dependent. A phase II trial randomized patients to either receive gemcitabine 2200 mg/m2 over a standard 30 minute infusion or gemcitabine 1500 mg/m2 at a fixed rate of 10 mg/m2/min weekly x 3 every 4 weeks. The fixed rate infusion of 10 mg/m2/min was associated with a higher response rate of 16.6% v 2.7%, longer median survival 6.1 v 4.7 months, and a higher percentage of patients surviving one year or more, 23% v 0%. The fixed rate infusion schedule was also associated with significantly higher median gemcitabine triphosphate levels in peripheral circulating mononuclear cells after each infusion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study to Determine the Safety, Maximum Tolerated Dose, and Efficacy of Biweekly Oxaliplatin (Eloxatin) in Combination With Gemcitabine, Irinotecan, and 5-FU/Leucovorin (G-Flie) in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Exocrine Pancreas
Study Start Date : March 2004

Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine

Secondary Outcome Measures :
  1. To document any antitumor activity with biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine administered on this schedule

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of a solid tumor, OR advanced or metastatic disease that is refractory to conventional treatment or for which no standard therapy exists.
  2. Age > 18 years old.
  3. A performance status of ≥ 60 on the Karnofsky scale
  4. Life expectancy of at least 12 weeks.
  5. Patients must give written informed consent as per institutional and federal regulatory requirements.
  6. No chemotherapy, immunotherapy or radiotherapy for at least four weeks prior to entry in the study (six weeks for nitrosureas or mitomycin C). Patients may not receive concurrent chemotherapy, immunotherapy or radiotherapy while participating in this study. Patients may not receive concurrent treatment with any other investigational drug while on this protocol.
  7. Patients must have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
  8. Absolute granulocyte count of > 1,500/mm3 and a platelet count > 100,000/mm3.
  9. Patients must have adequate liver and renal function defined by a bilirubin of ≤ 2.0 mg/dl, and a creatinine of ≤ 1.5 mg/dl respectively.
  10. Patients must be able to stay in the general area for the duration of their treatment on this clinical research study.
  11. Men and women who are fertile must use adequate contraception. Premenopausal women must have a negative pregnancy test documented prior to study entry.
  12. Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Exclusion Criteria:

Individuals excluded from participating in this study are described below.

  1. Women who are pregnant or breast-feeding
  2. Patients with clinical signs of brain involvement or leptomeningeal disease.
  3. Patients with progressive sensory neuropathy or progressive hearing loss or tinnitus.
  4. Patients with other serious illness or medical conditions, including but not limited to the following:

    • congestive heart failure or angina pectoris
    • previous history of myocardial infarction within 1 year from study entry
    • uncontrolled hypertension or arrhythmias
    • active infections
    • unstable diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00220649

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United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
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Principal Investigator: Peter Kozuch Continuum Cancer Center

Layout table for additonal information Identifier: NCT00220649    
Other Study ID Numbers: 175-03
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 17, 2009
Last Verified: August 2009
Keywords provided by St. Luke's-Roosevelt Hospital Center:
solid tumors or adenocarcinoma of the exocrine pancreas
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors