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DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors Clinical research trials and DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors. DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors clinical trial. Human subjects often receive the most effective healthcare possible for their DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors  DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining DJ-927 with capecitabine in treating patients who have locally advanced or metastaticsolid tumors.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of DJ-927 and capecitabine in patients with locally advanced or metastatic solid tumors. - Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients. Secondary - Determine the toxicity profile of this regimen in these patients. - Determine the possible pharmacokinetic interactions of this regimen in these patients. - Determine the antitumor activity of this regimen in these patients. OUTLINE: This is an open-label, dose-escalation, nonrandomized, multicenter study. - Course 1: Patients receive oral DJ-927 once on day 1 and oral capecitabine once on days 0 and 1 and twice daily on days 2-14. - Course 2: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 2-15. - Course 3 and all subsequent courses: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 1-14. All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of DJ-927 and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients receive treatment at the MTD. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor - Locally advanced or metastatic disease - Minimally pretreated - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Bilirubin no greater than 1.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Gastrointestinal - No prior chronic diarrhea - No swallowing and/or malabsorption problems - No diarrhea (excess of 2-3 stools/day above normal frequency in the past month) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No prior severe or life-threatening hypersensitivity reaction to a taxane or capecitabine - No concurrent serious infection - No neuropathy grade 2 or greater - No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No other severe or uncontrolled underlying medical disease that would preclude study participation - No psychiatric disorder that would preclude giving informed consent or study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent anticancer biologic therapy Chemotherapy - Recovered from prior chemotherapy - No other concurrent anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - Recovered from prior radiotherapy - No concurrent anticancer radiotherapy - Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective Surgery - At least 4 weeks since prior major surgery and recovered - No prior major surgery in the stomach or small intestine Other - At least 4 weeks since prior myelosuppressive therapy - More than 28 days since prior investigational drugs (including analgesics and/or antiemetics) - No other concurrent anticancer therapy - No other concurrent anticancer cytotoxic therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChrisTakimoto, Study Chair, Cancer Therapy and Research Center
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Patricia LoRusso 313-745-8860
Cancer Therapy and Research Center *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Chris Takimoto 210-562-1725
Additional Information:
Study ID Numbers: CDR0000346368; WSU-085503MP4F,DAIICHI-927A-PRT006
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077077
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. BMS-214662 in Treating Patients With Advanced Solid Tumors
2. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
3. Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
4. Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer
5. Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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