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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: DJ-927

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080834

MDA-2003-0749

DAIICHI-927A-PRT004

CDR0000356034

Details and patient eligibility

About

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).

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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