Know Cancer

or
forgot password

A Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Head & Neck Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Head & Neck Cancer


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 Objectives:

1. To assess quantitative toxicities in this group of patients treated with this regimen.

2. To assess response rate in this group of patients treated with this regimen

3. To investigate in an exploratory manner, the association of tumor markers p53,
p21waf1/cip1, bcl-xL, bcl-2 and bax (evaluated by immunohistochemistry) with response
rate using pre- and post-treatment biopsies.

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 on days 1 and 15 every 28 days over 30-60 minutes.

- Paclitaxel: 150 mg/m2 IV 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

toxicity notations made during weeks 3, 5, 7 & 9 of each cycle

Safety Issue:

Yes

Principal Investigator

Susanne Arnold, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kentucky

Authority:

United States: Institutional Review Board

Study ID:

04-H&N-16-EL

NCT ID:

NCT00176241

Start Date:

December 2005

Completion Date:

November 2009

Related Keywords:

  • Head and Neck Cancer
  • head and neck
  • Gemcitabine
  • Paclitaxel
  • radiation
  • low-dose radiation
  • recurrent
  • metastatic
  • Head and Neck Neoplasms

Name

Location

University of KentuckyLexington, Kentucky  40536-0098