Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	WCCC-CO-02904 NCI-5912, NCT00054548

Objectives

1. Determine the maximum tolerated dose of oblimersen when administered in combination with carboplatin and paclitaxel in patients with advanced solid tumors.
2. Determine the quantitative and qualitative toxic effects of this regimen in these patients.
3. Determine the pharmacokinetics of this regimen in these patients.
4. Determine, preliminarily, the antitumor activity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

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



• No lymphoma



• No known brain metastases

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)

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/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Liu G, Kolesar J, McNeel DG, et al.: A phase I pharmacokinetic and pharmacodynamic correlative study of the antisense Bcl-2 oligonucleotide g3139, in combination with carboplatin and paclitaxel, in patients with advanced solid tumors. Clin Cancer Res 14 (9): 2732-9, 2008.[PUBMED Abstract]

Lalich M, Wilding G, Kolesar J, et al.: A Phase I study of antisense Bcl-2 Oligonucleotide (G3139) in combination with carboplatin (C) and paclitaxel (T) in patients with advanced solid tumors. [Abstract] J Clin Oncol 24 (Suppl 18): A-13006, 602s, 2006.

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Glenn Liu, MD, Protocol chair		Ph: 608-265-8689; 800-622-8922

Registry Information
Official Title		A Phase I Study of Antisense Bcl-2 Oligonucleotide (G3139) in Combination with Carboplatin and Paclitaxel in Patients with Advanced Solid Tumors
Trial Start Date		2002-11-08
Trial Completion Date		2008-05-09
Registered in ClinicalTrials.gov		NCT00054548
Date Submitted to PDQ		2002-10-23
Information Last Verified		2007-10-05
NCI Grant/Contract Number		CA62491, CA14520

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