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A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer


OBJECTIVES:

Primary

- Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with
refractory or recurrent advanced colorectal cancer.

- Determine the maximum tolerated dose of this regimen in these patients.

- Determine a safe dose for this regimen in these patients.

Secondary

- Determine the pharmacokinetic profile of this regimen in these patients.

- Determine the safety profile of this regimen in these patients.

- Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study.

Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day
1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression
or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity. A maximum of 12 patients receive
treatment at the MTD.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed colorectal cancer

- Radiologic evidence of advanced disease

- At least 1 measurable lesion at least 20 mm OR at least 10 mm by spiral CT scan

- Indicator lesions in a previously irradiated field are allowed provided the
irradiated lesion has clearly progressed OR a new lesion has developed in the
irradiated field

- Failed 1, and only 1, line of prior chemotherapy for advanced/metastatic disease

- Disease progression during chemotherapy OR within 6 months after completion of
treatment

- No symptomatic brain metastases meeting any of the following criteria:

- Unstable

- Inadequately controlled with fixed-dose oral steroids

- Potentially life-threatening

- Required radiotherapy with the past 28 days

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

Hepatic

- AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
are present)

- Bilirubin < 1.5 times ULN

- No hepatitis

- No cirrhosis

Renal

- Creatinine < 1.5 times ULN

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- HIV negative

- No preexisting neuropathy ≥ grade 2

- No active or uncontrolled infection

- No other serious illness or medical condition

- No chronic alcohol abuse

- No known hypersensitivity to systemic liposomal formulations or compounds chemically
related to OSI-7904L or oxaliplatin

- No prior psychiatric or neurologic condition that would preclude study compliance or
giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 21 days since prior immunotherapy

- At least 21 days since prior monoclonal antibody therapy

Chemotherapy

- See Disease Characteristics

- At least 21 days since prior chemotherapy and recovered*

- No prior oxaliplatin NOTE: *Alopecia allowed

Endocrine therapy

- See Disease Characteristics

- At least 21 days since prior hormonal therapy

Radiotherapy

- See Disease Characteristics

- At least 21 days since prior radiotherapy and recovered

- No prior radiotherapy to more than 25% of bone marrow reserve

Surgery

- Recovered from prior surgery

Other

- At least 21 days since prior tyrosine kinase inhibitor therapy

- More than 21 days since prior investigational agents

- No other concurrent anticancer therapy

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0

Safety Issue:

Yes

Principal Investigator

Patrick Schoffski, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Hannover Medical School

Authority:

United States: Federal Government

Study ID:

EORTC-16033

NCT ID:

NCT00081237

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • recurrent colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms

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