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| Sponsor: | Princess Margaret Hospital, Canada |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00074022 |
Purpose
RATIONALE: GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. Combining GTI-2040 with docetaxel may kill more tumor cells
PURPOSE: Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating patients who have recurrent, metastatic, or unresectable locally advanced non-small cell lung cancer, prostate cancer, or other solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Biological: GTI-2040 Drug: docetaxel |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I/2 Study of GTI-2040 Combined With Docetaxel In Metastatic Or Unresectable Locally Advanced Non-Small Cell Lung Cancer |
| Study Start Date: | November 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Cohorts of 3-6 patients receive escalating doses of GTI-2040 and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RP2D) is defined as the dose preceding the MTD.
PROJECTED ACCRUAL: A total of 12-48 patients (12-18 for phase I [closed to accrual as of 8/5/2004] and 15-30 for phase II) will be accrued for this study within 4-16 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Measurable disease
No bone-only disease
No known progressive or symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
One, and only one, prior chemotherapy regimen for advanced disease (not including adjuvant therapy) allowed
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent anticoagulant therapy
Contacts and Locations| Canada, Ontario | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Chair: | Natasha Leighl, MD, FRCPC | Princess Margaret Hospital, Canada |
More Information
| Study ID Numbers: | CDR0000341677, PMH-PHL-017, NCI-6104 |
| Study First Received: | December 10, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00074022 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer unspecified adult solid tumor, protocol specific recurrent prostate cancer stage IIIA non-small cell lung cancer |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer stage III prostate cancer stage IV prostate cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Prostatic Neoplasms Neoplasms, Glandular and Epithelial |