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| ID | Type | Description | Link |
|---|---|---|---|
| CO 02904 | |||
| NCI-5912 | |||
| WCCC-CO-02904 | |||
| U01CA062491 | U.S. NIH Grant/Contract | View source |
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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.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of G3139 in combination with carboplatin and paclitaxel.
II. To determine the quantitative and qualitative nature of toxicities of G3139 with carboplatin and paclitaxel.
III. To measure G3139 activity in peripheral blood lymphocytes by quantitating Bcl-2/Bax expression and transcription, as well as T-cell functioning and signaling.
IV. To measure G3139 activity in tumor biopsy specimens by quantitating Bcl-2/Bax expression and transcription.
V. To determine the pharmacokinetics of carboplatin, paclitaxel, and G3139, as well as intratumoral G3139 levels.
VI. To screen various signal transduction pathways that may be affected by Bcl-2 down-regulation in PBMC and tumor biopsy specimens in order to better understand the mechanism of G3139 chemosensitization.
VII. To seek preliminary evidence of antitumor activity for the combination of G3139, carboplatin, and paclitaxel.
OUTLINE: This is a dose-escalation study of oblimersen.
Patients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
An additional cohort of 12-15 patients receives treatment as above with oblimersen at the MTD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (oblimersen sodium, paclitaxel) | Experimental | Patients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 12-15 patients receives treatment as above with oblimersen at the MTD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oblimersen sodium | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) defined as the highest safely tolerated dose where at most 1 patient experiences a dose-limiting toxicities (DLT) and the next higher dose having at least 2 patients who experience DLT | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of G3139 in combination with paclitaxel and carboplatin | All PK parameters will be summarized by dose level with simple summary statistics: means, medians, ranges, and standard deviations (if numbers and distribution permit). | Day 1, 4, 5, and 6 of course 1 |
| Disease response as having either progressive disease (PD), stable disease (SD), a partial response (PR), or a complete response (CR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Wilding | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| C408162 | oblimersen |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| paclitaxel | Drug | Given IV |
|
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| laboratory biomarker analysis | Other | Correlative studies |
|
| pharmacological study | Other | Correlative studies |
|
|
Disease response will be summarized in tabular format showing the number and percent of patients in each category/dose level. Dose-response relationships will be explored by logistic regression analysis. |
| Up to 6 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |