Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Radiation for Metastatic or Recurrent Head & Neck Cancer

Stopped early · Phase 1

Conditions studied: Head and Neck Cancer

In brief

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 Gemcitabine dose escalation and then with low-dose radiation escalation. Treatment Schedule Treatment will be administered on an inpatient or outpatient basis. * Gemcitabine:2000 to 3000mg/m2 IV (in the vein) on days 1 and 15 every 28 days over 30-60 minutes. * Paclitaxel: 150 mg/m2 IV(in the vein)on days 1 and 15 every 28 days over 60 minutes. * Low Dose Radiation: 50-80 cGy twice daily on days 1, 2, 15, \& 16 every 28 days at least 4 hours apart.

Key facts

Study ID

NCT00176241

Run by

Susanne Arnold

People needed

7

Starts

2005-12-01

Expected to finish

2008-11-01

Last updated by the study team

2015-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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