Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Temozolomide

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.

Combination chemotherapy was administered for up to 6 cycles

Paclitaxel, carboplatin, temozolomide

Montasur Shaheen, MD

The number of melanoma cases has been steadily increasing over the past few decades. For many patients with metastatic melanoma, there are no effective therapies. The goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.

Over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. The rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. Temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. Specifically, a previous phase I study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. The efficacy of this combination is now being studied in this phase II trial.

Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Phase II Trial of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.

The time from treatment initiation to death by any cause.

All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade.

The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

New Mexico Cancer Care Alliance

Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.

Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles

Chemotherapy Combination

Age, Categorical

Sex: Female, Male

White non-Hispanic

White Hispanic

Black

Race/Ethnicity, Customized

United States

Region of Enrollment

Brain

Bone

Liver

Lung

Other visceral organs

Regional Lymph Nodes

Site of Metastasis

Surgery

Radiation

Chemotherapy

Interferon

Immune Vaccines

Previous Therapy

Montaser Shaheen, MD, PhD

Complete response (CR)

Partial response (PR)

Stable disease

Progressive disease (PD)

ORR (CR + PR)

The 16 patients who completed treatment were evaluable for the endpoint of overall response rate.

Objective Response Rate (ORR)

The 16 patients who completed treatment were evaluable for survival analysis.

Overall Survival

Fatigue (Grade 1-2)

Fatigue (Grade 3-4)

Fever (Grade 1-2)

Fever (Grade 3-4)

Weight loss (Grade 1-2)

Weight loss (Grade 3-4)

Anorexia (Grade 1-2)

Anorexia (Grade 3-4)

Diarrhea (Grade 1-2)

Diarrhea (Grade 3-4)

Aspartate aminotransferase increased (Grade 1-2)

Aspartate aminotransferase increased (Grade 3-4)

Vomiting (Grade 1-2)

Vomiting (Grade 3-4)

Gastrointestinal Bleed (Grade 1-2)

Gastrointestinal Bleed (Grade 3-4)

Nausea (Grade 1-2)

Nausea (Grade 3-4)

Alanine aminotransferase increased (Grade 1-2)

Alanine aminotransferase increased (Grade 3-4)

Hyperbilirubinemia (Grade 1-2)

Hyperbilirubinemia (Grade 3-4)

Neutropenia (Grade 1-2)

Neutropenia (Grade 3-4)

Anemia (Grade 1-2)

Anemia (Grade 3-4)

Lymphopenia (Grade 1-2)

Lymphopenia (Grade 3-4)

Leukopenia (Grade 1-2)

Leukopenia (Grade 3-4)

Thrombocytopenia (Grade 1-2)

Thrombocytopenia (Grade 3-4)

Hyperglycemia (Grade 1-2)

Hyperglycemia (Grade 3-4)

Hypophosphatemia (Grade 1-2)

Hypophosphatemia (Grade 3-4)

Hypokalemia (Grade 1-2)

Hypokalemia (Grade 3-4)

Hyponatremia (Grade 1-2)

Hyponatremia (Grade 3-4)

Chest wall pain (Grade 1-2)

Chest wall pain (Grade 3-4)

Bone pain (Grade 1-2)

Bone pain (Grade 3-4)

Muscle weakness, lower limb (Grade 1-2)

Muscle weakness, lower limb (Grade 3-4)

Joint pain (Grade 1-2)

Joint pain (Grade 3-4)

Drowsiness (Grade 1-2)

Drowsiness (Grade 3-4)

Peripheral Sensory Neuropathy (Grade 1-2)

Peripheral Sensory Neutropenia (Grade 3-4)

Pericardial effusion (Grade 1-2)

Pericardial effusion (Grade 3-4)

Edema limbs (Grade 1-2)

Edema limbs (Grade 3-4)

Alopecia (Grade 1-2)

Alopecia (Grade 3-4)

Rash (Grade 1-2)

Rash (Grade 3-4)

Dry mouth (Grade 1-2)

Dry mouth (Grade 3-4)

All patients who had received at least one dose of on-study treatment were evaluable for toxicity.

Safety Profile

The 16 patients who completed treatment were evaluable for progression-free survival.

Time to Progression

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Small Cell Lung Carcinoma

Lung Diseases

Recurrence

Respiratory Tract Diseases

Small Cell Lung Cancer

Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days).

Cycle length is 21 days.

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.

Temozolomide at 75 mg/m2 per day from day 2 to day 6.

Combination Treatment - Cohort 1

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.

Temozolomide at 100 mg/m2 per day from day 2 to day 6.

Combination Treatment - Cohort 2

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.

Temozolomide at 125 mg/m2 per day from day 2 to day 6.

Combination Treatment - Cohort 3

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.

Temozolomide at 150 mg/m2 per day from day 2 to day 6.

Combination Treatment - Cohort 4

Fa-Chyi Lee, MD

The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.

The objective of the research study is to test a combination of drugs to treat small cell lung cancer which has spread beyond the lungs (extensive cancer) or come back after earlier treatment (recurrent cancer).

Combination Paclitaxel, Carboplatin and Temozolomide

Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.

Temozolomide was administered at different dose levels (see Cohorts 1-4) until the maximum tolerated dose (MTD) was reached. MTD is the dose at which 0/6 or 1/6 patients in the cohort experience dose limiting toxicity (DLT) during the first 4 week cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will have occurred when the patient has 1 or more Grade 4 hematologic or nonhematologic toxicities. A DLT must occur in the first cycle of the combination and must be at least possibly attributed to the treatment regimen. Toxicities will be graded according to the NCI CTCAE Version 3.0.

Tumor response is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 as determined by the investigator. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): \>= 30% reduction from baseline in the sum of the longest diameter of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Progressive disease (PD) for target lesions: \>= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma	NCT01009515	Melanoma	Paclitaxel, car...	18 Years -	New Mexico Cancer Care Alliance
Combination Paclitaxel, Carboplatin and Temozolomide	NCT00249964	Lung Diseases Cancer	Combination Tre... Combination Tre... Combination Tre... Combination Tre...	18 Years -	New Mexico Cancer Care Alliance

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