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A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer


OBJECTIVES:

- Determine the efficacy of bortezomib, in terms of response rate and stable disease
rate, in patients with recurrent or metastatic colorectal cancer.

- Determine the toxicity of this drug in these patients.

- Determine the time to progression and response duration in patients treated with this
drug.

- Determine whether there is a relationship between levels of transcription factors NF
kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that
is incurable with conventional therapy

- Metastatic or recurrent disease

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan

- Disease must be accessible to biopsy

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1 OR

- Karnofsky 70-100%

Life expectancy

- More than 3 months

Hematopoietic

- Absolute granulocyte count at least 1,500/mm^3

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.25 times upper limit of normal (ULN)

- AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases
present)

Renal

- Creatinine no greater than 1.25 times UNL OR

- Creatinine clearance at least 50 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No other active malignancy within the past 3 years except curatively treated
nonmelanoma skin cancer or carcinoma in situ of the cervix

- No grade 1 or greater peripheral neuropathy due to prior chemotherapy

- No significant traumatic injury within the past 21 days

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No more than 1 line of prior chemotherapy (including any combination of fluorouracil,
irinotecan, and/or oxaliplatin) for metastatic disease

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

- Prior adjuvant chemotherapy allowed

- No concurrent cytotoxic chemotherapy

Radiotherapy

- More than 4 weeks since prior radiotherapy and recovered

- No prior radiotherapy to measurable target lesion unless disease progression has
occurred after radiotherapy

- No concurrent radiotherapy to the sole site of measurable disease

Surgery

- More than 21 days since prior major surgery

Other

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Amit M. Oza, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

CDR0000258488

NCT ID:

NCT00052507

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

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