Status:
COMPLETED
Paclitaxel and Bortezomib in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop ...
Detailed Description
OBJECTIVES: Primary * To identify the maximum tolerated dose of paclitaxel in combination with bortezomib in patients with metastatic or unresectable solid tumor malignancies that involve an activat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant solid tumor that involves an activated Ras/Raf/MAPK pathway, including the following:
- Breast cancer
- Prostate cancer
- Colon cancer
- Pancreatic cancer
- Ovarian cancer
- Non-small cell lung cancer
- Melanoma
- Papillary thyroid cancer
- Metastatic or unresectable disease
- Standard curative or palliative measures do not exist or are no longer effective
- No newly diagnosed, untreated, or uncontrolled brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/μL
- WBC ≥ 3,500/μL
- Platelet count ≥ 100,000/μL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN for tumor involvement of the liver)
- Creatinine ≤ 2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No neuropathy ≥ grade 1 with pain within the past 14 days
- No active infections
- No myocardial infarction within the past 6 months
- No NYHA class III or IV heart failure
- No uncontrolled angina
- No severe uncontrolled ventricular arrhythmias
- No evidence of acute ischemia or active conduction system abnormalities by ECG
- Any ECG abnormality at screening must be documented by the investigator as not medically relevant
- No hypersensitivity to bortezomib, boron, or mannitol
- No serious medical or psychiatric illness likely to interfere with study participation
- PRIOR CONCURRENT THERAPY:
- Prior paclitaxel or bortezomib allowed
- At least 4 weeks since prior chemotherapy and/or radiotherapy
- More than 14 days since other prior investigational drugs
- No other concurrent investigational agents
- No other concurrent anticancer agents, including chemotherapy and biologic agents
- No concurrent recombinant interleukin-11 (Neumega®)
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00667641
Start Date
March 1 2007
End Date
February 1 2009
Last Update
May 10 2011
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903