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A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 InstituteDetroit, Michigan  48201
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Cancer Therapy and Research CenterSan Antonio, Texas  78229