A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
Collecte de données
Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 2004
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 3 sites
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, United StatesVoir le siteBarbara Ann Karmanos Cancer Institute
Detroit, United StatesCancer Therapy and Research Center
San Antonio, United States