A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum
18 Years
N/A
Both
Colorectal Cancer
Trial Information
A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum
OBJECTIVES:
Primary
- Determine the objective tumor response rate in patients with progressive locally
advanced or metastatic adenocarcinoma of the colon or rectum treated with DJ-927 as
second-line treatment.
Secondary
- Determine the duration of response in patients treated with this drug.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival time in patients treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these
patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
prior first-line treatment regimen (irinotecan-containing vs oxaliplatin-containing).
Patients receive oral DJ-927* on day 1. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
NOTE: *Patients receive 1 of 2 selected doses to confirm the previously established maximum
tolerated dose
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 56-62 patients (28-31 per stratum) will be accrued for this
study within 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Progressive locally advanced or metastatic disease
- Received 1 prior irinotecan- or oxaliplatin-containing regimen
- At least 1 measurable lesion
- Target lesion must be outside field of prior radiotherapy
- 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 ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- ALT and AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
are present)
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Gastrointestinal
- No difficulty with swallowing
- No malabsorption
- No diarrhea (excess of 2-3 stools/day above normal frequency) within the past month
- No history of chronic diarrhea
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No concurrent serious infection
- No other concurrent severe or uncontrolled underlying medical condition that would
preclude study participation
- No neuropathy ≥ grade 2
- No history of any severe or life-threatening hypersensitivity reaction
- No psychiatric disorder that would preclude study compliance
- No other malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent biologic therapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior myelosuppressive chemotherapy and recovered
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- Localized radiotherapy to non-indicator lesions for pain relief 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
- More than 28 days since prior investigational agents (including analgesics and/or
antiemetics)
- No other concurrent anticancer therapy
- No other concurrent cytotoxic therapy
- No concurrent grapefruit products
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Peter Cheverton, MD, ChB, MMED, RadT
Investigator Role:
Study Chair
Investigator Affiliation:
Daiichi Pharmaceuticals
Authority:
United States: Federal Government
Study ID:
CDR0000356034
NCT ID:
NCT00080834
Start Date:
February 2004
Completion Date:
August 2006
Related Keywords:
- Colorectal Cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- recurrent colon cancer
- recurrent rectal cancer
- stage III colon cancer
- stage IV colon cancer
- stage III rectal cancer
- stage IV rectal cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Colorectal Neoplasms
- Colonic Neoplasms
Name | Location |
|---|---|
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| MD Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
