• Safety (phase I) [ Designated as safety issue: Yes ]
• Efficacy, as measured by objective tumor response rate (phase II) [ Designated as safety issue: No ]

• Safety (phase I)
• Efficacy, as measured by objective tumor response rate (phase II)

• Maximum tolerated dose (phase I) [ Designated as safety issue: Yes ]
• Progression-free survival (phase II) [ Designated as safety issue: No ]
• Overall survival (phase II) [ Designated as safety issue: No ]

• Maximum tolerated dose (phase I)
• Progression-free survival (phase II)
• Overall survival (phase II)

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with pemetrexed may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see how well they work in treating patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors.

OBJECTIVES:

Primary

• Determine the safety and feasibility of paclitaxel albumin-stabilized nanoparticle formulation when administered with pemetrexed disodium in patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors. (Phase I)
• Determine the efficacy of this regimen, as measured by objective tumor response rate (RECIST criteria), in these patients. (Phase II)

Secondary

• Determine the maximum tolerated dose of this regimen in these patients. (Phase I)
• Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle formulation and pemetrexed disodium in these patients. (Phase I)
• Determine the progression-free survival and overall survival of patients treated with this regimen. (Phase II)
• Evaluate the frequency and severity of toxicities associated with this regimen. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by an open-label, phase II study.

• Phase I: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
• Phase II: Patients receive pemetrexed disodium and paclitaxel albumin-stabilized nanoparticle formulation at the MTD as in phase I. After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

• Breast Cancer
• Lung Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

• Drug: paclitaxel albumin-stabilized nanoparticle formulation
• Drug: pemetrexed disodium

DISEASE CHARACTERISTICS:

• Cytologically or histologically proven advanced non-small cell lung cancer (NSCLC), breast cancer, or other solid tumors (phase I)

  • Evaluable disease (i.e., bone metastases, pleural fluid, ascites) allowed

• Cytologically or histologically proven NSCLC, meeting all of the following criteria (phase II):

  • Stage IIIB (pleural effusion) or IV disease

    • NSCLC that has progressed or recurred after first-line therapy for stage IIIA or IIIB disease allowed
  • Progressed or recurred after prior platinum-based therapy
  • Stable disease as best response to first-line therapy allowed

  • Must have measurable disease by RECIST criteria

    • Disease in previously irradiated sites is considered measurable if there is clear disease progression after radiotherapy
• No third space fluid which cannot be controlled by drainage
• Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) are eligible provided they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Male or female
• Menopausal status not specified
• Zubrod performance status (PS) 0-2 (phase I) or 0-1 (phase II)
• Life expectancy ≥ 3 months
• Creatinine clearance ≥ 45 mL/min
• AST and ALT < 2.5 times upper limit of normal
• Bilirubin normal
• Platelet count ≥ 100,000/mm³
• ANC ≥ 1,500/mm³
• Must be able to take and retain oral medication
• Must be able to take folic acid, vitamin B12, and dexamethasone
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• No preexisting peripheral neuropathy ≥ grade 2
• No other active malignancy
• No other clinically significant illness
• No other serious medical or psychiatric illness, including serious active infection
• No history of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, pemetrexed disodium, or a taxane
• No serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from all prior therapy
• No NSAIDS for 2 days before (5 days for long acting NSAIDS), during, and for 2 days after pemetrexed disodium
• At least 2 weeks since prior radiotherapy
• At least 4 weeks since prior chemotherapy
• Any number of prior chemotherapy regimens allowed (phase I)

• No more than 2 prior chemotherapy regimens for advanced NSCLC (phase II)

  • Patients with recurrent stage III disease may have had ≤ 2 prior treatments (including primary therapy, adjuvant therapy, or concurrent chemoradiotherapy)
• No prior paclitaxel
• No prior paclitaxel albumin-stabilized nanoparticle formulation
• No prior pemetrexed disodium
• No other concurrent chemotherapy, biologic therapy, or targeted therapies
• No other concurrent anticancer or investigational therapy
• No concurrent radiotherapy
• No concurrent enrollment in another clinical study in which investigational procedures are performed or investigational therapies are administered