A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
Data Collection
Neoplasms
Treatment Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, United StatesSee the locationBarbara Ann Karmanos Cancer Institute
Detroit, United StatesCancer Therapy and Research Center
San Antonio, United States