A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Chris H. Takimoto, MD, PhD, FACP
Investigator Affiliation:
Cancer Therapy and Research Center, Texas
Authority:
United States: Federal Government
Study ID:
CDR0000346368
NCT ID:
NCT00077077
Start Date:
February 2004
Completion Date:
January 2006
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
| Cancer Therapy and Research Center | San Antonio, Texas 78229 |
