Recruiting
Phase 2

Integrative Chemotherapy

Sponsor:

Seattle Cancer Treatment and Wellness Center

Code:

NCT00323583

Conditions

Adenocarincoma of Pancreas

Stage III Pancreatic Cancer

Stage IVA Pancreatic Cancer

Stage IVB Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

paclitaxel

oxaliplatin

leucovorin

5-fluorouracil

glutathione

Study Details

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.

Conditions

Adenocarincoma of Pancreas

Stage III Pancreatic Cancer

Stage IVA Pancreatic Cancer

Stage IVB Pancreatic Cancer

Study ID

NCT00323583

Start date

May, 2006

Status verified date

May, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

paclitaxel

oxaliplatin

leucovorin

5-fluorouracil

glutathione

calcium and magnesium

Chemotherapy

Chemoprotection

Complementary and alternative therapy

Primary outcome measure

  • Clinical response rate (PS improvement by ECOG score, analgesic dose reduction) [ Time Frame: undefined ]
  • Response Rate Recist (Uni-Dimensional) Criteria [ Time Frame: undefined ]
  • Progression free survival [ Time Frame: undefined ]
  • Median survival [ Time Frame: undefined ]
  • Overall survival [ Time Frame: undefined ]
  • Quality of life [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Ben Chue, MD

206-292-2277

Nick Chen, MD

206-292-2277nickc@seattlecancerwellness.com

Locations

Seattle Cancer Treatment and Wellness Center

Recruiting

Seattle, Washington, United States, 98112

Contacts

Nick Chen, MD

206-292-2277nickc@seattlecancerwellness.com

Jerry Kaufman

206-292-2277jerryk@seattelcancerwellness.com

More Information

Sponsor

Seattle Cancer Treatment and Wellness Center

Last update posted

May 8, 2007

Last verified

May, 2007

Keywords

  • Cancer
  • Pancreatic Cancer
  • Cancer Alternative Therapies
  • Living with Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Cancer Treatment and Wellness Center on 2007-05-08.