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

NCT01200342 | Terminated Phase 2 Results

• 1 other identifier: 2010-0188
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Keywords

Uveal melanoma; Carboplatin; Genasense; Paclitaxel; oblimersen; GCP

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)

  Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): \>30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): \>20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s

  Following two 3-week cycles

• Number of Participants With Response

  Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): \>30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): \>20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s

  Following two 3-week cycles

Study Arms (1)

Genasense + Paclitaxel + Carboplatin

EXPERIMENTAL

Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m\^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration \[AUC)\]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.

Drug: Genasense; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Genasense DRUG

900 mg by vein over 1 hour on Days 1, 3, and 5 of a 21 day cycle.

Also known as: G3139, Oblimersen

Genasense + Paclitaxel + Carboplatin

Paclitaxel DRUG

175 mg/m\^2 by vein over 3 hours on Day 3 of a 21 day cycle following Genasense.

Also known as: Taxol

Genasense + Paclitaxel + Carboplatin

Carboplatin DRUG

Carboplatin starting dose in mg (AUC= 6) is administered over 30 minutes IV Piggyback (IVPB). Carboplatin will be dosed after Paclitaxel dose on Day 3 every 3 weeks. The total dose of Carboplatin is calculated using a formula based upon a participant's glomerular filtration rate (GFR in mL/min) and Carboplatin target area under the concentration (AUC).

Also known as: Paraplatin

Genasense + Paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a history of uveal melanoma and documented metastatic disease
• 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.
• 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.
• 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.
• At least 4 weeks (28 days) since prior radiotherapy to \> 20% of the bone marrow.
• Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
• Patients must have ECOG performance status of 0 - 2.
• Patients should be 18 years of age or older.
• 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
• 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.
• 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.
• 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.

You may not qualify if:

• Patients who have received prior therapy with Genasense, any taxane or any of cisplatin analogues for systemic disease.
• Patients whose site of primary melanoma is not in the choroid.
• 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.
• Patients with brain metastasis or history of brain metastasis (es).
• Patients who are pregnant or breastfeeding.
• Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
• Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
• 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.
• Patients with a known hypersensitivity to cremophor containing anti-cancer agents.
• 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.
• Patients with Gilbert's Syndrome.
• Patients must not have had major surgery within the past 14 days.
• Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
• Known HIV disease or infection.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genta Incorporated: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Melanoma; Uveal Melanoma

Interventions

oblimersen; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Sapna P. Patel, MD / Assistant Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Sapna P. Patel, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 11, 2016
• Results First Posted: February 11, 2016

Record last verified: 2016-01

Locations

US (1)