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A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel And Cisplatin With Or Without Erlotinib In Patients With Metastatic Or Recurrent Squamous Cell Carcinoma Of the Head And Neck


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck

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Trial Information

A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel And Cisplatin With Or Without Erlotinib In Patients With Metastatic Or Recurrent Squamous Cell Carcinoma Of the Head And Neck


The Study Drugs:

Erlotinib is designed to block the activity of a protein found on the surface of many tumor
cells. Blocking the protein may control tumor growth and survival. This may stop tumors
from growing.

Docetaxel is a drug designed to target and destroy cancer cells.

Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer
cells, which may cause them to die. It also may stop replication and transcription of the
cancer cells' DNA (the genetic material of cells).

Carboplatin is designed to interfere with the growth of cancer cells by stopping cell
division, which may cause the cells to die.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 study groups. You have an equal chance of being
assigned to either group.

Both groups will receive up to 6 3-week cycles (18 weeks total) of docetaxel and cisplatin
or carboplatin, combined with "study tablets." Your treating doctor will decide if you
should receive cisplatin or carboplatin. One group's "study tablet" will be erlotinib,
while the other group's "study tablet" will be a placebo (a tablet that looks like the study
drug but has no active ingredients). Neither you nor the study doctor will know if you are
receiving erlotinib or placebo. However, if needed for your safety, the study doctor will
be able to find out what you are receiving.

If the disease does not get worse and you are tolerating the "study tablets" after the end
of the combination chemotherapy treatment, you will continue to receive the "study tablet"
every day for as long as you are benefiting. This is called the "maintenance" phase of the
study.

Study Drug Administration:

Cisplatin/Carboplatin and docetaxel will be given by vein once every 3 weeks. Both drugs
will be given on Day 1 of every cycle. Docetaxel is given first, over 1 hour.
Cisplatin/Carboplatin is given second, over 2 hours.

Erlotinib (or placebo) will be taken every day by mouth, with a cup (8 ounces) of water.
You should take the tablet on an empty stomach, at least 1 hour before or 2 hours after a
meal. You should take the tablet at around the same time each day. Your eating habits
around the time you take the tablet should stay the same while you are on study. lf you
vomit, you should not take another tablet until your next scheduled dose.

You will continue taking the erlotinib (or placebo) every day for as long as you are
benefiting.

Study Visits:

Within 7 days before Cycles 2-6:

- You will be asked about any side effects you may be experiencing or any drugs you may
be taking.

- You will have a physical exam, including a measurement of vital signs and weight.

- Blood (about 2-3 teaspoons) will be drawn for routine tests.

- You will be asked about your current smoking status and tobacco use.

- You will be given your next supply of study tablets, and any returned tablets will be
counted.

- If your doctor thinks it is needed, women who are able to become pregnant will have a
blood (about 1 teaspoon) or urine pregnancy test.

Within 7 days before Cycles 3 and 5:

- You will have a CT or MRI scan and chest x-rays to check the status of the disease. If
your doctor thinks it is needed, you may have more imaging scans.

- You will complete a quality-of-life questionnaire. The questionnaire will take about 15
minutes to complete.

"Maintenance" Phase:

Every 21 days:

- You will be asked about any side effects you may be experiencing and about any drugs
you may be taking.

- You will have a physical exam, including a measurement of vital signs and weight.

- Blood (about 2-3 teaspoons) will be drawn for routine tests.

- You will be asked about your current smoking status and tobacco use.

- You will be given your next supply of study tablets, and any returned capsules will be
counted.

If your doctor thinks it is needed, women who are able to become pregnant will have a blood
(about 1 teaspoon) or urine pregnancy test.

Every 6 weeks:

- You will have a CT or MRI scan and chest x-rays to check the status of the disease. If
your doctor thinks it is needed, you may have more imaging scans.

- You will complete a quality-of-life questionnaire. The questionnaire will take about 15
minutes to complete.

Length of Study:

You will stay on study for up to 6 cycles of chemotherapy and study tablets (erlotinib or
placebo), followed by the "maintenance" phase. You will be taken off study if the disease
gets worse or if you have intolerable side effects. You may also stop receiving study drugs
or if the doctor thinks it is in your best interest to stop.

If you leave the study early for any reason, you should try to complete all of the
end-of-study testing.

End-of-Treatment Visit:

For all patients, the End of Treatment visit will take place about 30 days after the last
dose of study drug/placebo. The following tests and procedures will be performed:

- You will be asked about any side effects you may be experiencing and about any drugs
you may be taking.

- You will have a physical exam, including measurement of vital signs.

- Blood (about 2-3 teaspoons) will be drawn for routine tests.

- If your doctor thinks it is needed, women who are able to become pregnant will have a
blood (about 1 teaspoon) or urine pregnancy test.

Follow-Up Contact:

After the End-of-Treatment visit, you may be contacted every 6 weeks to collect information
about disease status, any treatment you have received, and any other side effects you have
experienced. You (or your family members or designees) may be contacted by telephone, in
writing, by e-mail, or during clinic visits. This information may also be collected by
checking your medical record.

This is an investigational study. Erlotinib is approved by the FDA for treatment of
non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin,
and carboplatin are all FDA approved and commercially available.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Histologically confirmed metastatic or recurrent SCCHN of the oral cavity,
oropharynx, hypopharynx or larynx. Metastatic or recurrent lesions of the nasopharynx
and sinus are excluded.

2. Radiologically measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as
>/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.
Measurable lymph nodes are required to be >/= 15 mm in size (short axis diameter).

3. Age >/= 18 years

4. ECOG PS
5. Adequate bone marrow, hepatic and renal function defined by: ANC >/= 1.5 x 109/L;
Platelet count >/= 100 x 109/L; Total bilirubin Alkaline phosphatase
6. Patients with reproductive potential (eg, females menopausal for less than 1 year and
not surgically sterilized) must practice effective contraceptive measures for the
duration of study drug therapy and for at least 30 days after completion of study
drug therapy. Female patients of childbearing potential must provide a negative
pregnancy test (serum or urine)
7. Written informed consent to participate in the study according to the investigational
review board (IRB) or independent ethics committee (IEC).

Exclusion Criteria:

1. Histology other than squamous cell carcinoma.

2. Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx.

3. Prior chemotherapy for metastatic or recurrent disease.

4. Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to
randomization.

5. Patients with known, untreated brain metastases. Patients with treated (irradiated or
resected) brain metastases are eligible if treatment was completed more than 28 days
prior to study entry and if clinical neurologic function is stable.

6. Pre-existing peripheral neuropathy >/= grade 2.

7. History of poorly controlled gastrointestinal disorders that could affect the
absorption of the study drug (eg, Crohn's disease, ulcerative colitis). Patients
requiring feeding tubes are permitted.

8. Other active malignancies requiring chemotherapy treatment within 2 years prior to
randomization, except for adequately treated basal cell or squamous cell skin cancer
or in situ cervical or breast cancer or superficial, resected melanoma.

9. Serious underlying medical condition which would impair the ability of the patient to
receive protocol treatment, in the opinion of the treating physician.

10. History of allergic reactions to compounds of similar chemical composition to the
study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or
other drugs formulated with polysorbate 80.

11. Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast
cancer.

12. Dementia or significantly altered mental status that would prohibit the understanding
and giving of informed consent.

13. Women who are pregnant or breast-feeding and women or men not practicing effective
birth control.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Median Progression Free Survival of Patients from 4 Months to 6.5 Months

Outcome Time Frame:

4 Months for Arm B to 6.5 Months in Arm A

Safety Issue:

Yes

Principal Investigator

William N. William Jr., MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0395

NCT ID:

NCT01064479

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • SCCHN
  • Oral cavity
  • Oropharynx
  • Hypopharynx
  • Larynx
  • Tarceva
  • Erlotinib
  • OSI-774
  • Docetaxel
  • Taxotere
  • Cisplatin
  • Platinol
  • CDDP
  • Placebo
  • Chemotherapy
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030