Please assess the completion status of the following clinical trial:

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

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. 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.~2. 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.~3. 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.~4. 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.~5. 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.~6. Patients must have an ANC 1,500/µl \& platelet count 100,000/µl obtained within 28 days prior to registration.~7. 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.~8. 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.~9. All patients must have a Zubrod Performance Status of 0,1 or 2.~10. Peripheral neuropathy, if present, must be Grade 1.~11. Patients must be informed of investigational nature of this study \& must sign \& give written informed consent in accordance with institutional \& federal guidelines.~Exclusion Criteria:~1. 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.~2. 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.~3. 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.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 1 (Type: EXPERIMENTAL): None

Based on this trial design, predict the completion outcome and termination type (if applicable).