Colon Cancer Clinical Trial

Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas

Summary

This phase I trial is studying the side effects and best dose of oxaliplatin when given together with irinotecan in treating young patients with refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer cells.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of oxaliplatin when administered with irinotecan in pediatric patients with refractory solid tumors or lymphomas.

II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients.

SECONDARY OBJECTIVES:

I. Determine, preliminarily, the antitumor activity of this regimen in these patients.

II. Correlate UGT and BCRP genotype with the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of oxaliplatin.

Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed refractory malignant solid tumor or lymphoma

Intrinsic brain stem tumors and optic pathway tumors do not require histologic verification
No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists

Measurable or evaluable disease

Evaluable disease is defined as a tumor that cannot be measured using a ruler or calipers, but can be assessed to determine disease progression or complete response, such as any of the following:

Positive lesions on metaiodobenzylguanidine (MIBG) or bone scan
Metastatic bone marrow disease
Elevated tumor markers
Presence of a malignant pleural effusion
No leukemia
Performance status - Karnofsky 50-100% (for patients > 10 years of age)
Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
Not specified
Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3 (transfusion independent)
Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT ≤ 5 times ULN
Albumin ≥ 2 g/dL
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min

Creatinine based on age as follows:

No greater than 0.8 mg/dL (for patients age 5 and under)
No greater than 1.0 mg/dL (for patients age 6 to 10)
No greater than 1.2 mg/dL (for patients age 11 to 15)
No greater than 1.5 mg/dL (for patients age 16 and over)
No arrhythmia on EKG
No evidence of dyspnea at rest
No exercise intolerance
Pulse oximetry > 94% on room air and no evidence of pulmonary fibrosis by chest radiograph* or CT scan
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
Weight ≥ 10 kg
Neurologic deficits relatively stable for ≥ 1 week before study entry (patients with CNS tumors only)
No electrolyte (e.g., sodium, potassium, bicarbonate, calcium, magnesium, and phosphate) abnormality ≥ grade 2 (electrolyte supplementation allowed)
No uncontrolled infection
No history of life-threatening allergy to camptothecin derivatives or platinum agents
No sensory or motor peripheral neuropathy ≥ grade 2
No elevation of amylase or lipase ≥ grade 2
Able to tolerate enteral medications (e.g., cefixime, cefpodoxime, or loperamide)
Recovered from all prior immunotherapy
At least 7 days since prior hematopoietic growth factors
At least 7 days since prior antineoplastic biologic therapy
Prior stem cell transplantation or rescue without total-body irradiation (TBI) allowed provided ≥ 3 months have elapsed and there is no evidence of active graft-versus-host disease
No concurrent immunotherapy
No concurrent biologic therapy
More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
No prior oxaliplatin
No other concurrent chemotherapy
Concurrent steroids allowed provided dose has been stable for ≥ 7 days before study entry
See Biologic therapy
Recovered from all prior radiotherapy
At least 2 weeks since prior local palliative small port radiotherapy
At least 6 months since prior TBI
At least 6 months since prior craniospinal, whole spinal, or whole lung/abdominal radiotherapy
At least 6 months since prior radiotherapy to ≥ 50 % of the pelvis
At least 6 weeks since other prior substantial radiotherapy to the bone marrow
No concurrent radiotherapy
No other concurrent investigational drugs
No other concurrent anticancer therapy
No concurrent cephalosporin antibiotics

No concurrent use of any of the following:

Phenytoin
Carbamazepine
Oxcarbazepine
Barbiturates
Rifampin
Phenobarbital
Azole antifungal agents
Aprepitant
Hypericum perforatum (St. John's wort)

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00101270

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

Check Your Eligibility

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

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

COG Phase I Consortium
Arcadia California, 91006, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00101270

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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