ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage IV non-small cell lung cancer

• Evidence of inoperable local recurrence or metastasis

• Bone metastases or other nonmeasurable disease may not be only evidence of metastasis

• Measurable disease documented radiographically

• No evidence of active brain metastases or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1 OR

• Karnofsky 80-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9 g/dL

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Bilirubin normal

• Alkaline phosphatase ≤ 2.5 times ULN (unless due to bone metastases and there is no radiologic evidence of hepatic metastases)

Renal

• Creatinine ≤ 1.5 mg/dL

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception for 1 month before and during study participation

• No prior allergy or hypersensitivity to study drug

• No other concurrent active malignancy

• No pre-existing peripheral neuropathy grade 1 or greater

• No other concurrent clinically significant illness

• No concurrent serious medical risk factor involving any of the major organ systems that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for metastatic disease

• More than 4 weeks since prior cytotoxic chemotherapy

• No concurrent doxorubicin

• No other concurrent taxanes

• No concurrent anthracyclines

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 weeks since prior radiotherapy to a major bone marrow-containing area

• More than 4 weeks since prior radiotherapy except to a non-target lesion

• Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since completion of radiotherapy

Surgery

• Not specified

Other

• Prior epidermal growth factor-targeted therapy allowed

• More than 4 weeks since prior investigational drugs

• No concurrent enrollment in another clinical trial in which investigational drugs are administered or investigational procedures are performed

• No concurrent treatment with any of the following:

• Ritonavir

• Saquinavir

• Indinavir

• Nelfinavir

• No concurrent anticonvulsants

• No other concurrent anticancer drugs

• No other concurrent investigational drugs