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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Adenocarincoma of Pancreas; Stage III Pancreatic Cancer; Stage IVA Pancreatic Cancer; Stage IVB Pancreatic Cancer	Drug: paclitaxel; Drug: oxaliplatin; Drug: leucovorin; Drug: 5-fluorouracil; Drug: glutathione; Drug: calcium and magnesium; Procedure: Chemotherapy; Procedure: Chemoprotection; Procedure: Complementary and alternative therapy	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study of Paclitaxel, Oxaliplatin, Leucovorin and 5-Fluorouracil (POLF) in Gemcitabine-Refractory Advanced Pancreatic Cancer
Study Start Date :	May 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Clinical response rate (PS improvement by ECOG score, analgesic dose reduction)
2. Response Rate Recist (Uni-Dimensional) Criteria
3. Progression free survival
4. Median survival
5. Overall survival
6. Quality of life

Secondary Outcome Measures :

1. Tolerance and Safety NCI-CTC version 2

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS

Patients with pathologically-proven pancreatic adenocarcinoma, who

1. are not candidate for surgery
2. are not candidate for radiation therapy and
3. have failed gemcitabine-based chemotherapy regimen

Gender Eligible for Study:

• Both

Prior Therapy:

• For advanced disease allowed as above;
• Oxaliplatin or 5-FU will be allowed but a subset analysis will be done for this group of patients;
• Tarceva and/or Erbitux allowed, but subset analysis will be done.

Allergies:

• No known allergy to one of the study drugs

PATIENT CHARACTERISTICS:

• No CNS metastases
• No peripheral neuropathy > grade 2
• ECOG Performance Status <=2
• Age ≤ 65
• No other serious concomitant illness
• Fully recovered from any prior therapy

Lower Age Limit:

• >18

Upper Age Limit:

• ≤ 65

Laboratory:

• ANC >1500
• Platelets >75,000
• Creatinine <=2.0

Other:

• For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception

Exclusion Criteria:

• Performance state >=3
• Uncontrolled serious concomitant disease
• Radiotherapy within the 6 weeks before Cycle 1‚ Day 1
• Surgery within the 2 weeks before Cycle 1‚ Day 1

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Ben Chue, MD	206-292-2277
Contact: Nick Chen, MD	206-292-2277	nickc@seattlecancerwellness.com

Locations

United States, Washington
Seattle Cancer Treatment and Wellness Center	Recruiting
Seattle, Washington, United States, 98112
Contact: Nick Chen, MD 206-292-2277 nickc@seattlecancerwellness.com
Contact: Jerry Kaufman 206-292-2277 jerryk@seattelcancerwellness.com

Sponsors and Collaborators

Seattle Cancer Treatment and Wellness Center

Investigators

Principal Investigator:	Ben Chue, MD	Seattle Cancer Treatment and Wellness Center

More Information

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ClinicalTrials.gov Identifier:	NCT00323583 History of Changes
Other Study ID Numbers:	CTCA06-02
First Posted:	May 9, 2006
Last Update Posted:	May 8, 2007
Last Verified:	May 2007

Keywords provided by Seattle Cancer Treatment and Wellness Center:

Cancer; Pancreatic Cancer; Cancer Alternative Therapies; Living with Cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Paclitaxel; Oxaliplatin; Albumin-Bound Paclitaxel; Fluorouracil	Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Antimetabolites, Antineoplastic; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs