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Phase I Dose-finding Study of E7070 in Combination with Irinotecan Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Phase I Dose-finding Study of E7070 in Combination with Irinotecan conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase I Dose-finding Study of E7070 in Combination with Irinotecan Clinical research trials and Phase I Dose-finding Study of E7070 in Combination with Irinotecan health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Phase I Dose-finding Study of E7070 in Combination with Irinotecan. Phase I Dose-finding Study of E7070 in Combination with Irinotecan Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase I Dose-finding Study of E7070 in Combination with Irinotecan clinical trial. Test subjects typically receive the most expert healthcare available for their Phase I Dose-finding Study of E7070 in Combination with Irinotecan condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I Dose-finding Study of E7070 in Combination with Irinotecan  Phase I Dose-finding Study of E7070 in Combination with Irinotecan
Phase I Dose-finding Study of E7070 in Combination with Irinotecan
For Condition: Pulmonary Cancer,Pulmonary Neoplasms,Colorectal Carcinoma,Colorectal Tumors,Colorectal Cancer
Status: Recruiting
Sponsor(s): Eisai Medical Research Inc ,
Synopsis: The purpose of this study is to find a safe and effective dose of E7070 when used in combination with irinotecan hydrochloride (CPT-11, Camptosar) in patients with cancer of the GI tract or lungs.
Details: Colorectal cancer (CRC) is the fourth most common form of cancer and the second most frequent cause of cancer-related mortality in the US. Although in its early stages the disease is readily curable by surgery alone, more than one quarter of patients have metastases at the time of presentation. Relatively few treatment options exist for patients who are refractory or have become resistant to first-line therapy with 5-FU. Lung cancer is the leading cause of cancer death in the developed world. In the US, there are more than 170,000 new cases and almost 160,000 deaths annually. Approximately 80% of cases are of non-small cell histology and the majority of patients present with either locally advanced (stage III) or metastatic (stage IV) disease. A recent comparison of four different chemotherapy regimens as first-line therapy did not identify any significant survival differences and concluded that there is an urgent need for new therapeutic approaches. The development of a combination of irinotecan with E7070 may produce a therapy that has superior efficacy to irinotecan alone in patients with CRC and provide a better tolerated second-line therapy for patients with Stage IIIb/IV NSCLC who have failed platinum-based chemotherapy. E7070 and irinotecan will be administered on Days 1 and 8 of a 21-day cycle according to one of two E7070 dose escalation schemes. Patients will remain on study treatment until they no longer have clinical benefit, they have disease progression, or they experience unacceptable toxicity (unresolved toxicity > 2 weeks) that leads to study withdrawal.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must have a histologically or cytologically confirmed tumor or metastic malignancy of the GI tract or lung, that is surgically unresectable, - Patients should not have received more than two previous regimens of chemotherapy plus capecitabine or 2 regimens plus antiangiogenic therapy (prior epidermal growth factor directed therapy does not constitute a previous regimen), - Patients must be aged >= 18 years, - Patients must be ambulatory and have a Karnofsky performance status >= 70%, - Patients must have a life expectancy of >= 3 months, - Patients must meet the following screening hematologic values: Hemoglobin >= 10g /dL, Absolute Neutrophil Count >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, - 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), - Patients must have serum creatinine <= 1.5 x ULN, - Patients must be willing and able to comply with the study protocol for the duration of the study, - 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: - Patients with a QTc>500 mb (Bazett's correction) at screening, - Patients who have received chemotherapy or radiation therapy (except palliative) or who have had major surgery within four weeks of treatment start, - Patients who have received chemotherapy without recovering from chemotherapy related toxicity at study entry, - Patients who have received palliative radiation therapy without recovering from radiation associated toxicity at study entry, - Patients with a history of hypersensitivity to irinotecan, - Patients who experienced >= Grade 3 toxicity during previous therapy with irinotecan, - 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), - Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception, - 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, - Patients with a history of conjugated hyperbilirubinemia, - Patients with clinically significant cardiac or cardiovascular impairment, - Patients with severe uncontrolled intercurrent infections, - Patients with organ allografts, - 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 musthave recovered from any associated toxicity. - Patients with a history of hypersensitivity to sulfonamides, - Any concurrent or previous malignancy of a different tumor type within five years of starting E7070 treatment except for adequately treated non-melanoma skin cancer or cervical intraepithelialneoplasia, - Patients with surgically resectable metastatic disease, - 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, - Patients with significant disease, in the Investigator’s opinion, that would exclude the patient from the study, or - Patients who are legally incapacitated.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
FrankRenshaw, Study Director, Eisai Medical Research Inc
Additional Information:
Study ID Numbers: E7070-A001-106;
Study Start Date: March 2003
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060567
Other Pulmonary Neoplasms Studies:
1. Phase I Dose-finding Study of E7070 in Combination with Irinotecan
Related Studies:
Other Pulmonary Neoplasms Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Phase I Dose-finding Study of E7070 in Combination with Irinotecan
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