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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041171 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. St. John's wort may interfere with the effectiveness of chemotherapy. It is not yet known if chemotherapy is more effective with or without St. John's Wort in treating solid tumors.
PURPOSE: Randomized phase III trial to compare the effectiveness of docetaxel with or without St. John's wort in treating patients who have solid tumors that cannot be removed by surgery.
Condition | Intervention | Phase |
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Adult Solid Tumor Breast Cancer Head and Neck Cancer Kidney and Urinary Cancer Male Reproductive Cancer Thorax and Respiratory Cancer |
Drug: Hypericum perforatum Drug: docetaxel Procedure: cancer prevention intervention Procedure: chemotherapy Procedure: complementary and alternative therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase III Randomized Study of Hypericum Perforatum (St. John's Wort) Combined With Docetaxel in Patients With Unresectable Solid Tumors |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients who have not been receiving chronic Hypericum perforatum (St. John's Wort) are assigned to group A, while a cohort of 8 patients who have been receiving chronic Hypericum perforatum are assigned to group B.
Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for new primaries and survival only.
PROJECTED ACCRUAL: Approximately 92 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study ID Numbers: | CDR0000069449, CLB-60002 |
Study First Received: | July 8, 2002 |
Last Updated: | January 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00041171 |
Health Authority: | United States: Federal Government |
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer recurrent non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer stage III bladder cancer recurrent bladder cancer stage IV bladder cancer stage III prostate cancer stage IV prostate cancer recurrent prostate cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage III squamous cell carcinoma of the lip and oral cavity stage III basal cell carcinoma of the lip stage III verrucous carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage IV basal cell carcinoma of the lip stage IV verrucous carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity |
Squamous cell carcinoma Adenoid cystic carcinoma Docetaxel Carcinoma, Adenoid Cystic Lung Neoplasms Metastatic squamous neck cancer with occult primary Carcinoma, squamous cell Laryngeal carcinoma Papilloma Salivary Gland Diseases Breast Diseases Bladder neoplasm Non-small cell lung cancer Skin Diseases |
Urinary Bladder Neoplasms Breast Neoplasms Carcinoma, Basal Cell Granuloma Recurrence Carcinoma Carcinoma, Small Cell Epidermoid carcinoma Nasopharyngeal carcinoma Head and Neck Neoplasms Hypopharyngeal cancer Carcinoma, Squamous Cell Carcinoma, Non-Small-Cell Lung Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |