DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma (cancer).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.

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