Bortezomib and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors

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

Summary

Phase I trial to study the effectiveness of combining bortezomib with paclitaxel in treating patients who have advanced or metastatic solid tumors. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with paclitaxel may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Bortezomib; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced or metastatic solid tumor for which there is no curative treatment

• No known brain metastases

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• 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 normal

• AST/ALT no greater than 2.5 times upper limit of normal (ULN)

• Creatinine no greater than ULN

• Left ventricular function at least lower limit of normal if received prior doxorubicin

• No grade II or IV tilt-table test

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No thrombotic event within the past 6 months

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior allergic reaction to compounds of similar chemical or biological composition to study drugs

• No other concurrent uncontrolled illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• Prior paclitaxel allowed

• At least 2 weeks since prior hormonal therapy

• No concurrent steroids or hormonal therapy except steroids to prevent hypersensitivity reactions to paclitaxel or hormonal therapy for non-disease-related conditions (e.g., insulin for diabetes)

• At least 4 weeks since prior radiotherapy

• At least 4 weeks since prior surgery

• Recovered from prior therapy

• No other concurrent investigational agents

• No concurrent combination anti-retroviral therapy for HIV-positive patients

• No concurrent anticoagulation therapy

• Concurrent pamidronate or zoledronate allowed for treatment of hypercalcemia or for palliation of skeletal metastases