Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma

NCT ID: NCT00568451

Last Updated: 2015-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2012-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving paclitaxel together with carboplatin is more effective than giving temozolomide alone in treating patients with melanoma.

PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel together with carboplatin or giving temozolomide alone works in treating patients with stage IV melanoma.

Detailed Description

OBJECTIVES:

• To assess the anti-tumor activity and toxicity profile of timed delivery of conventional paclitaxel and carboplatin (PC) in patients with stage IV melanoma who have received prior chemotherapy for their metastatic disease.
• To assess the anti-tumor activity and toxicity profile of timed delivery of conventional temozolomide (TMZ) chemotherapy in patients with stage IV melanoma who have received prior chemotherapy for their metastatic disease.
• To assess the anti-tumor activity and toxicity profile of timed delivery of conventional PC in patients with stage IV melanoma who have not received prior chemotherapy for their metastatic disease.
• To assess the anti-tumor activity and toxicity profile of timed delivery of conventional TMZ chemotherapy in patients with stage IV melanoma who have not received prior chemotherapy for their metastatic disease.
• To evaluate the changes of T-regulator cells, melanoma-specific functional parameters as a function of time in all four patient cohorts.

OUTLINE: Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no) and scheduled chemotherapy regimen (paclitaxel and carboplatin vs temozolomide).

Beginning at the predicted day of C-reactive peptide (CRP) peak levels, patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15 OR oral temozolomide alone on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for pharmacological studies. Samples are analyzed for CRP quantification via ELISA; presence and number of circulating blood T-regulator cells via immunophenotyping for CD4/CD25+ and CD4/fox-p3+ T cells; level of functional immunity against melanoma specific antigens (MART-1, tyrosinase, and gp100) and survivin in patients that are HLA-A2+ via intracellular staining; total number of cytotoxic T lymphocytes (CTLs) capable of reacting against melanoma targets via tetramer staining (Becton-Coulter); and quantification of interferon γ-producing, peptide-specific CTLs via multicolor conventional flow cytometry.

After completion of study treatment, patients are followed every 3 months for up to 2 years.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PC (previously treated)

Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal

paclitaxel

Intervention Type: DRUG

100mg/m\^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal

PC (chemo naive)

Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal

paclitaxel

Intervention Type: DRUG

100mg/m\^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal

TMZ (previously treated)

Previously chemotherapy treated cohorts: Temozolomide (TMZ)

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

150mg/m\^2 at cycle 1, 200mg/m\^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks

TMZ (chemo naive)

Chemotherapy-naive cohorts: Temozolomide (TMZ)

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

150mg/m\^2 at cycle 1, 200mg/m\^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks

Interventions

carboplatin

AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal

Intervention Type: DRUG

paclitaxel

100mg/m\^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal

Intervention Type: DRUG

temozolomide

150mg/m\^2 at cycle 1, 200mg/m\^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks

Intervention Type: DRUG

Other Intervention Names

Taxol; Temodar

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic melanoma

• Stage IV disease
• Progressive disease
• No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
• Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone for progressive disease
• Measurable disease as defined by RECIST criteria

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• ANC ≥ 1,500/mL
• Platelet count ≥ 100,000/mL
• Hemoglobin ≥ 9 g/dL
• Creatinine ≤ 2.5 x upper limit of normal (ULN)
• AST ≤ 3 x ULN
• Alkaline phosphatase ≤ 3.0 x ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 1 month after completion of study therapy
• No uncontrolled intercurrent illness including, but not limited to, any of the following:

• Active infection
• NYHA class III or IV congestive heart failure
• No history of other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
• Willing to provide research blood samples

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior therapy
• At least 4 weeks since prior radiotherapy
• At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)

• No prior chemotherapy treatment with agents similar to study drugs
• No prior chemotherapy in the metastatic setting (for chemo-naive patients)
• No concurrent enrollment in a different clinical study in which investigational procedures or agents are being used
• No other concurrent investigational agents
• No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svetomir Markovic, MD, PhD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC057F

Identifier Type: OTHER

Identifier Source: secondary_id

06-002547

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2010-01794

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC057F

Identifier Type: -

Identifier Source: org_study_id