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