Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more sensitive to the drugs.

PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with oblimersen in treating patients who have advanced solid tumors.

Further Study Information

OBJECTIVES:

• Determine the maximum tolerated dose of oblimersen when administered in combination with carboplatin and paclitaxel in patients with advanced solid tumors.

• Determine the quantitative and qualitative toxic effects of this regimen in these patients.

• Determine the pharmacokinetics of this regimen in these patients.

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

OUTLINE: This is a dose-escalation study of oblimersen.

Patients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

An additional cohort of 12-15 patients receives treatment as above with oblimersen at the MTD.

PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study within 1 year.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic or unresectable solid tumor for which no standard curative therapy exists

• No lymphoma

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

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

• No history of bleeding diathesis

Hepatic

• Bilirubin normal

• AST and ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine normal OR

• Creatinine clearance at least 60 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 before, during, and for 3 months after study

• No history of allergic reactions to compounds of similar chemical or biological composition to study drugs

• No pre-existing grade 2 or greater neuropathy

• No ongoing or active infection

• No other uncontrolled illness that would preclude study participation

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

• No HIV-positive patients receiving combination antiretroviral therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during course 1 of study

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No other concurrent chemotherapy for the malignancy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy for the malignancy

Surgery

• No concurrent surgery for the malignancy

Other

• No other concurrent investigational agents

• No other concurrent anticancer therapies (commercial or investigational)

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Glenn Liu

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00054548
Information obtained from ClinicalTrials.gov on December 14, 2011

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