| Exclusion Criteria: | 1) Prior irradiation to >/= 25% of the bone marrow (whole pelvis = 25%; a patient with prior whole pelvis irradiation is ineligible)
2) Prior radiation therapy, surgery, or treatment with an investigational agent within 4 weeks before treatment (Patients on LHRH analogs may be maintained on treatment)
3) One or more lung lesions with cavitation or any lesion invading and/or providing support for the wall of blood vessels (as assessed by CT and/or MRI)
4) Current use or anticipated need for drugs that are known CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine) during the course of the study.
5) Current use or anticipated need for drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. John's wort) during the course of study (Note: the use of dexamethasone as a premedication for docetaxel or paclitaxel is not an exclusion criterion)
6) Requirement for therapeutic anticoagulant therapy including daily aspirin (>325 mg/day) or non-steroidal anti-inflammatory agents known to inhibit platelet function. Low-dose anticoagulants, such as low-dose heparin or 1-2 mg/day of coumadin for prevention of deep venous thrombosis or maintenance of patency of central venous access devices is permitted.
7) Patients with active seizure disorder or untreated brain metastases (Patients with clniical evidence suggestive of new brain metastases are excluded if brain metastases have not been ruled out via CT or MRI imaging. Patients with previously diagnosed brain metastases are eligible if they have completed their radiation therapy to the CNS and have recovered from the acute effects of that treatment before enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable.)
8) Clinically significant gastrointestinal abnormalities including any of the following: inability to take oral medication; requiring intravenous alimentation; malabsorption syndromes; requiring treatment of active ulcer disease in the past 6 months; prior gastric resection; active gastrointestinal bleeding, related or unrelated to cancer, as evidenced by either hematemesis, hematochezia, or melena in the past 3 months
9) Any of the following within the 12 months before enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack or pulmonary embolus.
10) NCI CTCAE Grade 3 hemorrhage from any cause < 4 weeks before enrollment
11) Hemoptysis > 1/2 teaspoon of blood per day within 1 week of enrollment
12) History of Grade 3 or 4 toxicity or severe hypersensitivity reaction associated with prior adjuvant treatment with paclitaxel, docetaxel, carboplatin, cisplatin, gemcitabine or capecitabine.
13) Prior allergic reaction to drugs containing Cremophor EL (for patients receiving paclitaxel) or polysorbate 80 (for patients receiving docetaxel)
14) Known human immunodeficiency virus (HIV) seropositivity
15) Women who are pregnant or breast feeding
16) Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the patient inappropriate for entry into this study. |