Colon Cancer Clinical Trial

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

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).

View Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Colon Cancer

Phase:

Phase 2

Study ID:

NCT00080834

Recruitment Status:

Completed

Sponsor:

Daiichi Sankyo, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

University of New Mexico Cancer Research and Treatment Center
Albuquerque New Mexico, 87131, United States
MD Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Study ID:

NCT00080834

Recruitment Status:

Completed

Sponsor:


Daiichi Sankyo, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider