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NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer Clinical research trials and NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer. NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer  NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
For Condition: stage 4 colon cancer,adenocarcinoma of the colon,recurrent rectal cancer,Stage 4 rectal cancer,recurrent colon cancer,adenocarcinoma of the rectum
Status: No longer recruiting
Sponsor(s): NewBiotics ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of NB1011 in treating patients who have metastatic or recurrent colorectal cancer that has not responded to previous treatment.
Details: OBJECTIVES: - Determine the maximum tolerated dose of NB1011 in patients with fluoropyrimidine-resistant metastatic or recurrent colorectal cancer. - Determine the safety and toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the efficacy of this drug in these patients. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. - Patients receive NB1011 IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of NB1011 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. - Phase II: Additional patients receive NB1011 at the MTD as in phase I. Patients are followed at day 30 and then for 5 months. PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for the phase I portion of this study. A total of 15-25 patients will be accrued for the phase II portion of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic or recurrent colorectal adenocarcinoma that has progressed during or within 6 months of fluoropyrimidine-based therapy - Prior treatment with irinotecan with or without fluorouracil - Evaluable or measurable disease - Uni-dimensionally measurable disease allowed provided CEA is at least 2 times the upper limit of normal - No meningeal or CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL (regardless of liver metastases) - AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present) - PT and INR normal - PTT normal Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 50 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No known hypersensitivity to NB1011 or any excipient or vehicle in its formulation - No active or uncontrolled serious bacterial, viral, fungal, or parasitic infection - No prior or concurrent alcohol abuse or dependency - No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No concurrent medical or psychological condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - Recovered from prior anticancer chemotherapy - No concurrent fluoropyrimidine-based or thymidylate synthase inhibitor agents Endocrine therapy: - Not specified Radiotherapy: - Recovered from prior anticancer radiotherapy - No concurrent radiotherapy except palliative radiotherapy (to control a fracture or pain) provided index lesions are not involved Surgery: - Recovered from prior anticancer surgery Other: - At least 30 days since prior investigational agents - No other concurrent anticancer therapy - No concurrent disulfiram
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkPegram, Study Chair, David Geffen School of Medicine
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000069205; NB-1011-1001,NCI-V01-1689
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031616
Other Adenocarcinoma Of The Colon Studies:
1. FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen
2. SU011248 in Treating Patients With Metastatic Colorectal Adenocarcinoma (Cancer) That Has Not Responded to Previous Treatment With Irinotecan, Oxaliplatin, and a Fluoropyrimidine With or Without Bevacizumab
3. Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
4. Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
5. G3139 and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Related Studies:
Other adenocarcinoma of the colon Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
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