NCT00077077CompletedPhase 1
A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Daiichi Sankyo
- Locations
- 3
Study Overview
Brief Summary
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: This phase I trial is studying the side effects and best dose of DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed solid tumor
- •Locally advanced or metastatic disease
- •Minimally pretreated
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •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
- •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)
- •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
- •At least 4 weeks since prior major surgery and recovered
- •No prior major surgery in the stomach or small intestine
- •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
Exclusion Criteria
- Not provided
Investigators
Study Sites (3)
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