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

This study has been terminated.
(Pharmaceutical company no longer manufacturing drug)
Sponsor:
Collaborator:
Genta Incorporated
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01200342
First received: September 9, 2010
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

The goal of this clinical research is to learn if the combination of Genasense (oblimersen), carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety of this combination will also be studied.


Condition Intervention Phase
Melanoma
Drug: Genasense
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Genasense-Carboplatin-Paclitaxel-Combination in Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Following two 3-week cycles ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: December 2010
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genasense + Paclitaxel + Carboplatin
Genasense 900 mg by vein over 1 hour on days 1, 3, and 5 of a 21 day cycle. Paclitaxel 175 mg/m2 by vein over 1 hour on day 3 of a 21 day cycle. Carboplatin (AUC= 6) mg by vein over 30 minutes on day 3 of a 21 day cycle.
Drug: Genasense
900 mg by vein over 1 hour on days 1, 3, and 5 of a 21 day cycle.
Other Names:
  • G3139
  • Oblimersen
Drug: Paclitaxel
175 mg/m2 by vein over 1 hour on day 3 of a 21 day cycle.
Other Name: Taxol
Drug: Carboplatin
(AUC= 6) mg by vein over 30 minutes on day 3 of a 21 day cycle.
Other Name: Paraplatin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 </=5 mm in thickness or a pathologic lymph node that is >/= 15 mm on the short axis provided the CT slice is </= 5 mm in thickness or Superficial skin lesion 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 </=1.5 mg/dl, serum Lactate Dehydrogenase level no higher than 2.0 x UNL of the institution, transaminase (i.e., ALT and AST) levels no higher than 5 x UNL and serum creatinine </=1.5 mg/dl or estimated Creatinine Clearance >/=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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200342

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genta Incorporated
Investigators
Principal Investigator: Sapna P. Patel, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01200342     History of Changes
Other Study ID Numbers: 2010-0188
Study First Received: September 9, 2010
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Uveal melanoma
Carboplatin
Genasense
Paclitaxel
oblimersen
GCP

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 23, 2014