Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced 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 carboplatin and paclitaxel with oblimersen in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more sensitive to the drugs.

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

Details

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

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed solid malignancy that is metastatic or unresectable and for which no standard curative therapy exists; patients with lymphoma are excluded

• ECOG performance status 0, 1, or 2 (Karnofsky >= 60%)

• Life expectancy of greater than 3 months

• Leukocytes >= 3,000/mm^3

• Absolute neutrophil count >= 1,500/mm^3

• Platelets >= 100,000/mm^3

• Total bilirubin within normal institutional limits

• AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

• Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for three months after discontinuation of treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• Ability to understand and the willingness to sign a written informed consent document

• Patients will need to have a central line or nurse-placed PICC line in place prior to treatment on the protocol

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

• Patients may not be receiving any other investigational agents

• Patients with known brain metastases will be excluded from this clinical trial

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to G3139 or other agents used in study, unless approved by investigator

• No pre-existing grade >= 2 neuropathy

• No personal history of a bleeding diathesis given potential significant antiplatelet effects of therapy

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with G3139

• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study