Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

Inclusion Criteria:

Histologically confirmed metastatic or unresectable malignancy for which standard curative or palliative therapy does not exist or is no longer effective

Progressive disease manifested by the following parameters

For prostate cancer:

Must have castrate, metastatic disease defined by disease progression after surgical castration or treatment with a gonadotropin-releasing hormone (GnRH) analog (testosterone level less than 50 ng/mL)

Patients who have not undergone surgical orchiectomy should continue on medical therapies to maintain castrate levels of testosterone
Progressive metastatic disease on imaging studies (bone scan, CT scan, or MRI) OR metastatic disease and a rising prostate-specific antigen (PSA)
Biochemical progression indicated by at least 3 rising PSA values (obtained at least 1 week apart) from a baseline OR 2 rising PSA values (more than 1 month apart), where the percentage increase over the range of values is at least 25%
Patients who have received an antiandrogen as part of first-line hormonal therapy must have shown progression of disease off of the antiandrogen prior to study enrollment

For other solid tumors:

Development of new lesions or an increase in pre-existing lesions by bone scintigraphy, CT scan, MRI, positron emission tomography, or physical examination
Patients whose sole criterion for progression is an increase in a biochemical marker (e.g., carcinoembryonic antigen or CA 15-3) or an increase in symptoms are not eligible
Patients with metastatic disease must not be progressing to the extent as to require palliative treatment within 4 weeks of study entry
No active brain metastases
Performance status - Karnofsky 70-100%
More than 6 months
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT < 1.5 times ULN
PT ≤ 1.1 times ULN
Creatinine no greater than 1.4 mg/dL or within ULN
Creatinine clearance greater than 55 mL/min
No prior history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
No dyspnea ≥ grade 2 at rest on room air
No requirement for supplementary oxygen therapy or oxygen saturations ≤ 88%
No clinically significant pulmonary comorbidities that require medication (e.g., severe chronic obstructive pulmonary disease that could predispose patient to pulmonary toxicity)
QTc ≤ 450 msec for male patients (470 for female patients)
LVEF > 40% by echocardiogram or MUGA

Echocardiogram or MUGA required for patients with any of the following:

Myocardial infarction > 1 year ago
NYHA class I or II CHF
Atrial fibrillation
Right or left bundle branch block by EKG
No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
No myocardial infarction within the past year
No active ischemic heart disease within the past year
No New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
No poorly controlled angina
No uncontrolled dysrhythmia
No congenital long QT syndrome
No left bundle branch block
No other significant cardiac disease
No prior history of cardiac toxicity after receiving anthracyclines such as doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of severe hypersensitivity reaction to paclitaxel, docetaxel, or polysorbate 80
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No grade 2 or greater symptomatic peripheral neuropathy
No allergy to eggs or egg products
No other concurrent uncontrolled illness
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy to sole measurable lesion
No prior mantle-field radiotherapy
See Disease Characteristics
No concurrent surgery for sole measurable lesion
Recovered from prior therapy
At least 1 week since prior ketoconazole and recovered
At least 4 weeks since prior investigational anticancer therapeutic drugs
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent medications that prolong QTc interval

No concurrent medication used to control arrhythmias

Calcium blockers and beta blockers allowed
No other concurrent investigational agents
No other concurrent anticancer agents or therapies (investigational or commercial)

No concurrent CYP3A4 inhibitors, including any of the following:

Fluconazole
Itraconazole
Ketoconazole
Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin)
Nifedipine
Verapamil
Diltiazem
Cyclosporine
Grapefruit juice

No concurrent CYP3A4 inducers, including any of the following:

Carbamazepine
Phenobarbital
Phenytoin
Rifampin

No concurrent herbal extracts or tinctures with CYP3A4 inhibitory activity, including any of the following:

Hydrastis canadensis (goldenseal)
Hypericum perforatum (St. John's wort)
Uncaria tomentosa (cat's claw)
Echinacea angustifolia roots
Trifolium pratense (wild cherry)
Matricaria chamomilla (chamomile)
Glycyrrhiza glabra (licorice)
Dillapiol
Hypericin
Naringenin
Concurrent CYP3A4 substrates allowed