Status:
UNKNOWN
AMG 706 and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: AMG 706 may stop the growth of cancer cells by blocking blood flow to the cancer or by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and safety of AMG 706 when given in combination with gemcitabine hydrochloride in patients with advanced solid tumors or lymphoma. Seconda...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced solid tumors or lymphoma
- Must have measurable disease outside a previously irradiated field OR regrowth of tumor within a previously irradiated field
- Must be a candidate for gemcitabine hydrochloride treatment, in the opinion of the investigator
- No untreated or symptomatic brain metastases
- No tumors with direct bowel invasion
- No other hematological malignancies
- No non-small cell lung cancer of squamous cell histology or large central tumor (lesions ≥ 3 cm and located adjacent to or within the hilum or mediastinum)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant
- No nursing during and for 6 months after completion of study treatment
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- Negative pregnancy test
- Able to swallow oral medication
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min
- Albumin-adjusted calcium ≥ 8 mg/dL
- Urine protein \< 30 mg/dL by urinalysis or \< 1+ by dipstick OR \< 500 mg by 24-hour urine collection
- AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of liver metastasis or primary hepatic neoplasm)
- Bilirubin ≤ 2 times ULN
- PT ≤ 2.0
- INR or PTT ≤ 1.5 times ULN
- Systolic blood pressure (BP) ≤ 145 mm Hg and diastolic BP ≤ 85 mm Hg (stable antihypertensive medication allowed)
- No myocardial infraction within the past year
- No arterial thrombosis or deep vein thrombosis within the past year
- No unstable angina
- No congestive heart failure
- No New York Heart Association class III-IV cardiac disease
- No other unstable or uncontrolled disease or condition relating to or impacting cardiac function
- No HIV positivity
- No other condition that would preclude study participation, compliance, or follow-up assessments
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior enrollment into this study
- At least 1 month since prior investigational device or drug trial
- At least 1 month since prior major surgical procedure
- At least 3 weeks since prior systemic chemotherapy
- At least 2 weeks since prior radiotherapy
- At least 2 weeks since prior rifampin or phenobarbital
- At least 1 week since prior treatment with any of the following:
- Ketoconazole
- Itraconazole
- Clarithromycin
- Erythromycin
- Cyclosporine or tacrolimus
- Nefazodone
- Herbal medications containing Hypericum perforatum (St. John's wort)
- At least 1 week since prior and no concurrent warfarin
- Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin \[≤ 2 mg/day\] or low molecular weight heparin) for venous or arterial access devices allowed
- No prior or concurrent kinase insert domain-receptor inhibitors
- No concurrent chemotherapy, radiotherapy, hormone-directed cancer therapy, or tumor-directed antibody therapy
- Gonadotropin releasing-hormone agonist therapy allowed
- No concurrent interferon
- No concurrent grapefruit juice or whole grapefruit
- No other concurrent standard or investigational drugs or antitumor treatment, including c-kit, platelet-derived growth factor, vascular endothelial growth factor, or epidermal growth factor inhibitors
- No elective surgery during or for 2 weeks after completion of the last dose of AMG 706
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00324597
Start Date
October 1 2005
Last Update
September 17 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781