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

Alternate Title

Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Over 18	NCI	SUMC-78808 NCI-5908, NCT00060112, 5908

Objectives

1. Determine the maximum tolerated dose and dose-limiting toxicity of oblimersen and gemcitabine in patients with advanced solid tumor or lymphoma.
2. Determine the effect of oblimersen on the pharmacokinetics and pharmacodynamics of gemcitabine in these patients.
3. Determine the toxic effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed malignancy for which there is no standard or effective curative or palliative therapy
  • Solid tumors and lymphoma allowed
  • Metastatic or unresectable disease



• Measurable or evaluable nonmeasurable disease
  • Evaluable nonmeasurable disease includes ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses not followed by CT scan or MRI, or cystic lesions
  • Disease characterized by elevated serum tumor marker alone is allowed



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent prophylactic colony-stimulating factors such as filgrastim (G-CSF) or sargramostim (GM-CSF)
• Concurrent interventional growth factors allowed
  • No growth factor administration within 24 hours before study chemotherapy
• Concurrent epoetin alfa allowed

Chemotherapy

• No more than 3 prior chemotherapy regimens
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• More than 2 weeks since prior hormonal therapy
• Concurrent megestrol for anorexia/cachexia allowed

Radiotherapy

• No prior pelvic or whole abdominal radiotherapy
• More than 4 weeks since prior radiotherapy

Surgery

• More than 4 weeks since prior major surgery

Other

• Recovered from prior therapy
• More than 4 weeks since prior investigational therapy
• No prior oblimersen
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

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

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 2.5 times upper limit of normal
• No history of portal hypertension
• No history of cirrhosis or hepatitis
• No radiographic evidence of cirrhosis and/or varices

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
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to oblimersen or other study agents
• No other concurrent uncontrolled illness that would preclude study participation
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance

Expected Enrollment

Approximately 15 patients will be accrued for this study within 6-8 months.

Outline

This is a dose-escalation study.

Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oblimersen and gemcitabine 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. Up to 10 additional patients receive treatment at the MTD.

Trial Contact Information

Trial Lead Organizations

Stanford Cancer Center

Branimir Sikic, MD, Protocol chair		Ph: 650-723-7688

Registry Information
Official Title		A Phase I Study of Oblimersen (Genasense, G3139) in Combination with Gemcitabine in Advanced Malignancies
Trial Start Date		2003-03-14
Trial Completion Date		2003-11-19 (estimated)
Registered in ClinicalTrials.gov		NCT00060112
Date Submitted to PDQ		2003-03-18
Information Last Verified		2008-08-12

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