Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Rochester
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178256
First received: September 12, 2005
Last updated: January 26, 2012
Last verified: January 2012
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Purpose
A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first purpose of this study is to determine the dose of paclitaxel which, when given in combination with radiation therapy, will provide the greatest effect have the least side effects. To determine this, patients will be put on the study in groups of 3. The dose for each additional group will be higher than the previous dose until the maximum tolerated dose is reached. The second purpose is to determine if radiation therapy with paclitaxel is more effective in treating lung cancer than radiation therapy alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: Paclitaxel Procedure: Radiation Therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers |
Resource links provided by NLM:
Further study details as provided by University of Rochester:
Primary Outcome Measures:
- Define the maximum tolerated dose (MTD) using this dose schedule. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 41 |
| Study Start Date: | June 1998 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Paclitaxel
On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Procedure: Radiation Therapy
Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed lung cancer, excluding small cell carcinoma
- Inoperable stage I (T1-2N0) and II (T1-2N1, T3N0) disease, or stage IIIA (T3N1 andT1-3N2M0) and IIIB (TxN3M0, T4NxM0) diseases according to the American Joint Committee of Cancer criteria 1998
- The primary tumor must be radiographically measurable.
- Age > 18.
- Karnofsky performance status > 70.
- FEV1 sufficient for patients to tolerate radiation therapy which is at the discretion of the radiation oncologist, usually > 800 ml
- Labs: WBC > 3000; platelet count > 100,000; serum creatinine < 1.5 mg/dl or creatinine clearance >60 ml/min.
- Laboratory values must be obtained < 3 weeks prior to registration.
- A signed informed consent.
- Patients who failed prior chemotherapy are eligible. Patients with prior radiotherapy to the chest region are eligible as long as the normal tissue tolerance is not violated by repeat radiotherapy.
Exclusion Criteria:
- Patients with medical contraindication to chemotherapy or radiotherapy.
- Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including uncontrolled or unstable angina, uncontrolled congestive heart failure, and uncontrolled arrhythmia.
- Women who are pregnant.
- Patients with small cell carcinoma or mesothelioma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178256
Locations
| United States, New York | |
| University of Rochester, Dept. Radiation Oncology | |
| Rochester, New York, United States, 14642 | |
Sponsors and Collaborators
University of Rochester
Investigators
| Principal Investigator: | Yuhchyau Chen, MD, Ph.D | Universtiy of Rochester, Dept of Radiation Oncology |
More Information
No publications provided
| Responsible Party: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00178256 History of Changes |
| Other Study ID Numbers: | URCC 1597 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013