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

NCT00568451 | Terminated Phase 2 Results DMC

• 4 other identifiers: MC057FP30CA01508306-002547NCI-2010-01794
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

  Response that was noted on 2 consecutive evaluations for at least 4 weeks apart. CR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs.

  Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment

Secondary Outcomes (6)

• Time to Disease Progression

  up to 2 years

• Survival Time

  up to 2 years

• Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response

  up to 2 years

• Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment

  up to 2 years

• Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment

  up to 2 years

Study Arms (4)

PC (previously treated)

EXPERIMENTAL

Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)

Drug: carboplatin; Drug: paclitaxel

PC (chemo naive)

EXPERIMENTAL

Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)

Drug: carboplatin; Drug: paclitaxel

TMZ (previously treated)

EXPERIMENTAL

Previously chemotherapy treated cohorts: Temozolomide (TMZ)

Drug: temozolomide

TMZ (chemo naive)

EXPERIMENTAL

Chemotherapy-naive cohorts: Temozolomide (TMZ)

Drug: temozolomide

Interventions

carboplatin DRUG

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

PC (chemo naive); PC (previously treated)

paclitaxel DRUG

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

Also known as: Taxol

PC (chemo naive); PC (previously treated)

temozolomide 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

Also known as: Temodar

TMZ (chemo naive); TMZ (previously treated)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Carboplatin; Paclitaxel; Temozolomide

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This trial was stopped prior to achieving its accrual goals due to slow enrollment rate. Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Svetomir N. Markovic M.D., Ph.D.
• Organization: Mayo Clinic Cancer Center

markovic.svetomir@mayo.edu

507-284-2511

Study Officials

• Svetomir Markovic, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: June 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: April 1, 2012
• Last Updated: December 30, 2015
• Results First Posted: March 30, 2012

Record last verified: 2014-03

Locations

US (1)