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

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