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Dose-Finding Study of E7070 in Combination With Irinotecan
This study is ongoing, but not recruiting participants.
Study NCT00060567   Information provided by Eisai Inc.
First Received: May 7, 2003   Last Updated: August 27, 2009   History of Changes

May 7, 2003
August 27, 2009
March 2003
September 2008   (final data collection date for primary outcome measure)
To determine the Maximum tolerated dose of E7070 in combination with irinotecan in patients with GI tract, pancreatic or lung tumors. [ Time Frame: 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK ] [ Designated as safety issue: Yes ]
Maximum tolerated dose.
Complete list of historical versions of study NCT00060567 on ClinicalTrials.gov Archive Site
Safety, E7070 activity and Pharmacokinetics [ Time Frame: 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK ] [ Designated as safety issue: Yes ]
Safety, E7070 activity and Pharmacokinetics
 
Dose-Finding Study of E7070 in Combination With Irinotecan
Phase I Dose-Finding Study of E7070 in Combination With Irinotecan

E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one of two E7070 dose escalation schemes.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Cancer
  • Drug: E7070 + irinotecan combination
  • Drug: Irinotecan + E7070 combination
Other: Active combination of E7070 and irinotecan.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
80
July 2009
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must have a histologically or cytologically confirmed refractory small cell lung carcinoma or relapsed pancreatic cancer.
  2. Patients should not have received more than two previous regimens of chemotherapy (prior epidermal growth factor directed therapy antiangiogenic therapy, or capecitabine do not constitute a previous regimen),
  3. Patients must be aged >= 18 years,
  4. Patients must be ambulatory and have a Karnofsky performance status >= 70%,
  5. Patients must have a life expectancy of >= 3 months,
  6. Patients must meet the following screening hematologic values:

    • Hemoglobin >= 10g /dL
    • Absolute Neutrophil Count >= 1.5 x 10^9/L
    • Platelets >= 100 x 109/L,
  7. Patients must meet the following screening values for liver function:

    • Serum bilirubin <= 1.5 x upper limits of normal (ULN)
    • ALAT and ASAT <= 2.5 x ULN (unless related to liver metastases, in which case <= 5 x ULN),
  8. Patients must have serum creatinine <= 1.5 x ULN,
  9. Patients must be willing and able to comply with the study protocol for the duration of the study, and
  10. Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

Exclusion Criteria:

  1. Patients who have received chemotherapy or radiation therapy (except palliative) or who have had major surgery within four weeks of treatment start,
  2. Patients who have received chemotherapy without recovering from chemotherapy related toxicity (defined as grade 1 or less) at study entry,
  3. Patients who have received palliative radiation therapy without recovering from radiation associated toxicity at study entry,
  4. Patients with a history of hypersensitivity to irinotecan,
  5. Patients who experienced >= Grade 3 toxicity during previous therapy with irinotecan,
  6. Women who are pregnant or breastfeeding. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential),
  7. Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception,
  8. Any history of uncontrolled seizures; CNS disorders; or psychological, familial, sociological or geographical conditions, judged by the Investigator to be clinically significant, and/or potentially capable of precluding informed consent or adversely affecting compliance with the study protocol and follow-up schedule,
  9. Patients must not have untreated brain metastases (Patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 4 weeks prior to entry),
  10. Patients with a history of conjugated hyperbilirubinemia,
  11. Patients with clinically significant cardiac or cardiovascular impairment,
  12. Patients with severe uncontrolled intercurrent infections,
  13. Patients with organ allografts,
  14. Patients who are receiving investigational drug treatment, immunotherapy, or biologic therapy. Treatment must have been completed four weeks prior to entry into the study and patients must have recovered from any associated toxicity.
  15. Patients with a history of hypersensitivity to sulfonamides,
  16. Patients with surgically resectable metastatic disease,
  17. Patients who are known to be positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), Hepatitis C antibody, or human immunodeficiency virus,
  18. Patients with significant disease, in the Investigator's opinion, that would exclude the patient from the study,
  19. Patients who are legally incapacitated,
  20. Patients who have a repeated demonstration of QTc > 470 ms (Bazett's correction),
  21. Patients with tumor, including metastasis, that is surgically resectable,
  22. Patients with clinical symptoms from brain metastasis,
  23. Patients taking steroids for the treatment of brain metastases, or
  24. Patients with leptomeningeal metastasis,
  25. Patients who have a history of additional risk factors for torsades de pointes (e.g., heart failure) or family history of Long QT Syndrome.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00060567
Eisai Medical Services, Eisai Inc.
E7070-A001-106
Eisai Inc.
 
Study Director: Dan Rossignol, Ph.D Eisai Inc.
Eisai Inc.
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP