A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.

Inclusion Criteria:

• Age > 18 years.

• Advanced cancer potentially sensitive to vinorelbine:

• Breast cancer.

• Stage 3 or 4 non-small cell lung cancer.

• Non-Hodgkins lymphoma.

• Cancer of other histologic type, sensitive to vinca alkaloids.

• Rare tumor type with no standard treatment, for which single agent vinorelbine isappropriate therapy.

• Failure of standard treatment(s) of the tumor.

• Life expectancy of at least three months.

• ECOG performance level 0-2 or Karnofsky score 100-70.

• Hematological and serum chemistry results with defined ranges.

• Willingness and ability to provide written informed consent.

Exclusion Criteria:

• Pregnancy or lactation. In a woman of childbearing potential, a positive pregnancytest result, no pregnancy test result, or no use of reliable contraception, atbaseline. A postmenopausal woman will be considered to be of childbearing potentialuntil there has been amenorrhea for at least 12 consecutive months.

• Previous treatment with vinorelbine or mitomycin.

• Any history suggesting or demonstrating resistance to, lack of response to, orintolerance of any prior vinca alkaloid treatment.

• Active infection.

• Prior anticancer therapy completed within four weeks prior to the first day of studytreatment.

• Failure to have recovered from any toxicity of previous cancer treatment (patientswith alopecia will not be excluded).

• Participation in another experimental drug study within four weeks prior to the firstday of study treatment.

• Requirement for any concomitant chemotherapeutic agent other than the studymedication.

• Any investigator judgment that the individual would not be an appropriate studysubject.