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Trial · Interventional

Status unknownPhase 2Registry data

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

NCTNCT00323583 (opens ClinicalTrials.gov in a new tab)Other idCTCA06-02
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
80 participants (estimated)
Sponsor
Seattle Cancer Treatment and Wellness Center · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2006
Primary completion
Not stated
Completion
Not stated
First posted
9 May 2006 (estimated)
Last update posted
8 May 2007 (estimated)
Conditions
Adenocarincoma of Pancreas · Stage III Pancreatic Cancer · Stage IVA Pancreatic Cancer · Stage IVB Pancreatic Cancer

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007
  1. Ph 2

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

    NCT00323583

    Start May 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • paclitaxelDrug
  • oxaliplatinDrug
  • leucovorinDrug
  • 5-fluorouracilDrug
  • glutathioneDrug
  • calcium and magnesiumDrug
  • ChemotherapyProcedure
  • ChemoprotectionProcedure
  • Complementary and alternative therapyProcedure

Arms0

The registry lists no arms for this trial.

Primary outcomes6

Outcomes the sponsor listed as primary.

  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 outcomes(1)

  1. Tolerance and Safety NCI-CTC version 2

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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