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Dose-Finding Study of E7070 in Combination With Irinotecan
This study is ongoing, but not recruiting participants.
First Received: May 7, 2003   Last Updated: June 24, 2008   History of Changes
Sponsored by: Eisai Medical Research Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00060567
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: E7070 + irinotecan combination
Drug: Irinotecan + E7070 combination
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride E7070
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I Dose-Finding Study of E7070 in Combination With Irinotecan

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: March 2003
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Active combination of E7070 and irinotecan.
Drug: E7070 + irinotecan combination
Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination.
2
Active combination of E7070 and irinotecan.
Drug: Irinotecan + E7070 combination
Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
3
Active combination of E7070 and irinotecan.
Drug: Irinotecan + E7070 combination
Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060567

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Eisai Medical Research Inc.
Investigators
Study Director: Dan Rossignol, Ph.D Eisai Medical Research Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Medical Services )
Study ID Numbers: E7070-A001-106
Study First Received: May 7, 2003
Last Updated: June 24, 2008
ClinicalTrials.gov Identifier: NCT00060567     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:
E7070
Irinotecan
hydrochloride
gastrointestinal
cancer

Study placed in the following topic categories:
Signs and Symptoms
Irinotecan
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Irinotecan
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009