Status:
TERMINATED
Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Radiation for Metastatic or Recurrent Head & Neck Cancer
Lead Sponsor:
Susanne Arnold
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study seeks to establish the safety of gemcitabine, paclitaxel and low-dose radiation in recurrent, metastatic head and neck cancer through a two-stage dose escalation study, first with Gemcitabi...
Detailed Description
Objectives: 1\. To assess the MTD of low-dose fractionated radiation in combination with Gemcitabine and Paclitaxel in recurrent or metastatic head and neck cancer in the relapsed setting. Secondary...
Eligibility Criteria
Inclusion
- 18 yrs old or greater \& have histologically or cytologically proven metastatic or recurrent head \& neck cancer \& have failed at least 1 prior, but not more than 3 chemotherapeutic regimen. Patients who have recurred after previous surgery and/or radiation may participate in this trial, \& patients may have had prior neoadjuvant or adjuvant therapy. No restriction is placed on the # of cycles (beyond 1) of prior therapy, however, patients must not have received the combination of Gemcitabine \& Paclitaxel previously.
- Patients with known brain metastases are eligible for this trial if disease has been treated \& the patient is clinically stable \& documented by a stable or improved pretreatment CT or MRI of the brain to evaluate CNS disease within 28 days prior to registration.
- Patients must have measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable disease must be assessed within 28 days prior to registration \& non-measurable must be assessed within 42 days prior to registration. Pleural effusions, ascites \& lab parameters are not acceptable as only evidence of disease.
- Patients must have progressed after at least 1 prior chemotherapeutic regimen. Prior biologic therapy or radiation is permitted; however, at least 2 wks must have elapsed since completion of prior therapy \& patients must have recovered from all associated toxicities at time of registration.
- At least 3 wks must have elapsed since surgery (thoracic or other major surgeries) \& patients must have recovered from all associated toxicities at time of registration. Measurable or non-measurable disease must be present outside the area of surgical resection.
- Patients must have an ANC 1,500/µl \& platelet count 100,000/µl obtained within 28 days prior to registration.
- Patients must have adequate hepatic function documented by a serum bilirubin 1.5 x institutional ULN \& LFTs (SGOT or SGPT) 2.5 x the institutional ULN obtained within 28 days prior to registration.
- All patients with pulmonary metastasis must have an FEV1 of \> 1000 ml/min obtained within 28 days prior to registration \& must have PFTs with DLCO.
- All patients must have a Zubrod Performance Status of 0,1 or 2.
- Peripheral neuropathy, if present, must be Grade 1.
- Patients must be informed of investigational nature of this study \& must sign \& give written informed consent in accordance with institutional \& federal guidelines.
Exclusion
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 yrs.
- Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry \& for duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Patients taking drugs that are strong inducers of the enzyme CYP3A4 including anticonvulsants (i.e., phenytoin, phenobarbital, carbamazepine, or primidone) \& rifampin OR strong inhibitors of CYP3A4 (clarithromycin, itraconazole, and ketoconazole) will be excluded from this study. Patients must be off these medications for 2 wks in order to participate in this trial.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00176241
Start Date
December 1 2005
End Date
November 1 2008
Last Update
June 8 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kentucky
Lexington, Kentucky, United States, 40536