Genasense, Carboplatin, Paclitaxel (GCP) Combination in Uveal Melanoma

Study Drugs:

Oblimersen is designed to stop the body from making a protein that makes melanoma cells
resistant to chemotherapy drugs. This may make carboplatin and/or paclitaxel more effective.

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

Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive oblimersen by
vein over about 1 hour (+/- 5 minutes) on Days 1, 3, and 5 of each 21-day study "cycle." You
will receive dexamethasone by vein over about 30 minutes before you receive oblimersen to
help prevent side effects. You will take ibuprofen by mouth about 30 minutes before you
receive oblimersen.

You will receive paclitaxel by vein over about 3 hours (+/- 5 minutes) on Day 3 of each
cycle.

You will receive carboplatin by vein over about 30 minutes (+/- 5 minutes) on Day 3 of each
cycle.

Before you receive each of these drugs, you may receive other drugs to help prevent side
effects (such as nausea, vomiting, fever, and/or body aches). You may need to receive some
of these drugs for some time after you receive the study drugs. Your doctor will tell you
more about each of these drugs, about how they are given, and about any possible risks of
receiving them.

Study Visits:

Within 3 days before each cycle, blood (about 1 tablespoon) will be drawn for routine tests.

On Day 1 of each cycle:

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

- Your performance status will be recorded.

- You will be asked about any side effects you may be having.

- Women who are able to become pregnant will have a routine urine pregnancy test done.

Each week while you are on study, blood (about 1 teaspoon) will be drawn for routine tests.

Every 6 weeks, you will have the same imaging (CT and/or MRI) scans that you had at
screening to check the status of the disease. If the doctor thinks it is needed, you will
have a bone scan.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse or
intolerable side effects occur.

Your participation on the study will be over once you have completed the end-of-treatment
visit and follow-up.

End-of-Treatment Visit:

After you stop receiving the study drugs, the following tests and procedures will be
performed:

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

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- You will be asked about any side effects you may have had.

- You will have the same imaging (CTand /or MRI) scans that you had at screening to check
the status of the disease.

- Women who are able to become pregnant will have a routine urine pregnancy test done.

Follow-up:

Every 3 months for up to 2 years after you stop receiving the study drugs, you will be
called and asked about how you are doing and about any other drugs you may be receiving.
Each call will last about 3 minutes.

This is an investigational study. Carboplatin and paclitaxel are FDA approved and
commercially available for the treatment of a variety of cancers including breast, lung, and
ovarian cancers. Oblimersen is not FDA approved or commercially available. It is currently
being used for research purposes only.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients must have a history of uveal melanoma and documented metastatic disease

2. Patients must have at least one measurable lesion as per revised RECIST Criteria. A
measurable lesion is defined as a non-nodal lesions that is >/= 10 mm provided the CT
slice is /= 15 mm on the
short axis provided the CT slice is that is >/= 10 mm in diameter as assessed using calipers. Bone lesions are not
considered measurable.

3. Patients may be previously untreated or may have received prior systemic therapy but
no more than one systemic cytotoxic chemotherapy regimen and one targeted therapy for
metastatic disease.

4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine
or other therapy unless patients have progressed during therapy. If progression
occurred during therapy, patient must have recovered from any side effects before
starting GCP therapy.

5. At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow.

6. Lesions being used to assess disease status may not have been radiated or if so, must
have progressed during or after radiation therapy.

7. Patients must have ECOG performance status of 0 - 2.

8. Patients should be 18 years of age or older.

9. Patients must have adequate liver and renal function as defined by total bilirubin
institution, transaminase (i.e., ALT and AST) levels no higher than 5 x UNL and serum
creatinine /=60 ml/min

10. Patients must have adequate bone marrow function as defined by an absolute neutrophil
count of greater or equal to 1,500/mm3, and platelet count of greater or equal to
100,000/mm3.

11. Patients must sign an informed consent form indicating that they are aware of the
investigational nature of this study and in keeping with the policies of the
institution.

12. Females of childbearing potential (non childbearing is defined as greater than one
year post-menopausal or surgically sterilized) must use acceptable contraceptive
methods (abstinence, intrauterine device, oral contraceptive or double barrier
device), and must have a negative serum or urine pregnancy test within 7 days prior
to beginning treatment on this trial. Sexually active men must also use acceptable
contraceptive methods for the duration of time on study.

Exclusion Criteria:

1. Patients who have received prior therapy with Genasense, any taxane or any of
cisplatin analogues for systemic disease.

2. Patients whose site of primary melanoma is not in the choroid.

3. Patients who have a current history of neoplasm other than the entry diagnosis,
except for curatively treated non-melanoma skin cancer or carcinoma in situ of the
prostate or cervix or other cancers treated for cure and with a disease-free survival
longer than 2 years.

4. Patients with brain metastasis or history of brain metastasis (es).

5. Patients who are pregnant or breastfeeding.

6. Patients with current active infections requiring anti-infectious treatment (e.g.,
antibiotics, antivirals, or antifungals).

7. Patients with current peripheral neuropathy of any etiology that is greater than
grade one (1).

8. Patients with unstable or serious concurrent medical conditions are excluded.
Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent
(within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal
cord compression, superior vena cava syndrome, or any psychiatric disorder that
prohibits obtaining informed consent. PI or his designee shall make the final
determination regarding appropriateness of enrollment.

9. Patients with a known hypersensitivity to cremophor containing anti-cancer agents.

10. Patients with one or more of the following as the only manifestations of disease are
ineligible: Osteoblastic bone lesions, leptomeningeal disease, ascites,
pleural/pericardial effusions, carcinomatous lymphangitis, CNS metastases, lesions in
a previously irradiated area that have not shown definite progression, or disease
only inferred from laboratory tests or markers.

11. Patients with Gilbert's Syndrome.

12. Patients must not have had major surgery within the past 14 days.

13. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy
while on study.

14. Known HIV disease or infection.