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Paclitaxel

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Folate

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paclitaxel

oxaliplatin

leucovorin

5-fluorouracil

glutathione

calcium and magnesium

Chemotherapy

Chemoprotection

Complementary and alternative therapy

Ben Chue, MD

Nick Chen, MD

Jerry Kaufman

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, oxaliplatin, leucovorin and 5-fluoruracil, work in different ways separately and in combination to stop tumor cells from dividing so they stop growing or die. The use of metronomic dosing of chemotherapy minimizes side effects and increases efficacy by anti-angiogenic effects. The pilot study demonstrated promising responses in all patients. It is not yet known how effective this drug and dosing combination is in treating advanced pancreatic cancer.

PURPOSE: This non-randomized phase II trial is studying giving weekly doses of paclitaxel, oxaliplatin, leucovorin and 5-fluorouracil together as second or third-line therapy in treating patient with locally advanced unresectable or metastatic adenocarcinoma of the pancreas following demonstrated progression after first-line gemcitabine.

OBJECTIVES:

* The primary objective is to determine the effectiveness the chemotherapy combination in improving the experience of those with advanced pancreatic cancer in

  * Pain control and other aspects of quality of life
  * Reduction of the tumor size or stabilization of tumor growth
  * Progression free survival
  * Overall survival
* The secondary objective is to determine the safety of this chemotherapy combination by monitoring and the managing the potential side effects

DOSE REGIMEN OUTLINE: Paclitaxel 60mg/m2 IV weekly; Oxaliplatin 50mg/m2 IV weekly; Leucovorin 20 mg/m2 IV weekly, minimum of 40 mg; 5FU 425mg/m2 IV weekly; Weekly for 12 weeks; Calcium and magnesium 1gram each IV prior to and after Oxaliplatin therapy; Glutathione 1500mg/m2 prior to Oxaliplatin

DURATION OF STUDY PERIOD: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay greater than 3 weeks, 12 weeks initially, can than continue at discretion of investigator.

EXPECTED NUMBER OF PATIENTS: A total of 80 patients (40 second line of treatment and 40 third line or greater of treatment) will be enrolled for this study beginning in May 2006.

QUALITY OF LIFE: Quality of life will be assessed at baseline, each month of treatment and at the end of study therapy.

Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer

Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer

Seattle Cancer Treatment and Wellness Center

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Mouth and Tooth Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Plasmacytoma

Stomatitis

Mucositis

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

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Paraproteinemias

Blood Protein Disorders

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Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

Melphalan

chemoprotection

complementary or alternative medicine procedure

management of therapy complications

William I. Bensinger, MD

RATIONALE: Chemoprotective agents may protect normal cells from the side effects of chemotherapy. Ice chips or saline mouth rinse may lessen the severity or help prevent symptoms of mucositis or mouth sores in patients receiving melphalan and autologous stem cell transplant for multiple myeloma. It is not yet known whether ice chips are more effective than saline mouth rinse in reducing or preventing mucositis.

PURPOSE: This randomized phase III trial is studying ice chips to see how well they work compared to saline mouth rinse in reducing or preventing mucositis in patients receiving melphalan and autologous stem cell transplant for multiple myeloma.

OBJECTIVES:

* Compare the efficacy of administering ice chips vs room temperature normal saline oral rinse before, during, and after melphalan administration, in terms of reducing or eliminating grade 3 or 4 oral mucositis, in patients undergoing autologous peripheral blood stem cell transplantation (PBSCT) for multiple myeloma.
* Compare the number of days that IV narcotic therapy is required for oral mucositis pain in patients treated with these regimens.
* Compare the use of IV hydration and/or total parenteral nutrition after autologous PBSCT in patients treated with these regimens.
* Compare overall quality of life, in terms of ability to eat food and drink liquids, in patients treated with these regimens.

OUTLINE: This is a randomized, pilot study. Patients are stratified according to age (less than 60 years vs 60 years and over). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral ice chips 15 minutes before, during, and for 8 hours after melphalan infusion\* on day -2.
* Arm II: Patients receive room temperature normal saline oral rinses over 30 seconds 15 minutes before, during, and for 8 hours after melphalan infusion\* on day -2.

All patients undergo autologous peripheral blood stem cell transplantation (PBSCT)\* on day 0.

NOTE: \*Patients receive melphalan infusion and undergo autologous PBSCT on protocol FHCRC-1137.00.

Quality of life is assessed 3 days a week for 4 weeks.

After completion of study treatment, patients are followed for 28 days and then periodically thereafter.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study within 18 months.

Ice Chips or Saline Mouth Rinse in Reducing or Preventing Mucositis in Patients Receiving Melphalan and Autologous Stem Cell Transplant for Multiple Myeloma

A Prospective Randomized Pilot Study Using Ice Chips Versus Room Temperature Normal Saline Rinses Orally During Administration of Melphalan to Decrease the Severity and Duration of Oral Mucositis in Patients With Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplant

Fred Hutchinson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weekly Dosing of an Integrative Chemotherapy Combination to Treat Advanced Pancreatic Cancer	NCT00323583	Adenocarincoma ... Stage III Pancr... Stage IVA Pancr... Stage IVB Pancr...	paclitaxel oxaliplatin leucovorin 5-fluorouracil glutathione calcium and mag... Chemotherapy Chemoprotection Complementary a...	18 Years - 65 Years	Seattle Cancer Treatment and Wellness Center
Ice Chips or Saline Mouth Rinse in Reducing or Preventing Mucositis in Patients Receiving Melphalan and Autologous Stem Cell Transplant for Multiple Myeloma	NCT00118339	Multiple Myelom... Plasma Cell Neo...	chemoprotection complementary o... management of t...	18 Years -	Fred Hutchinson Cancer Center
Ice Chips or Saline Mouth Rinse in Reducing or Preventing Mucositis in Patients Receiving Melphalan and Autologous Stem Cell Transplant for Multiple Myeloma	NCT00118339	Multiple Myelom... Plasma Cell Neo...	chemoprotection complementary o... management of t...	18 Years -	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for chemoprotection