Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide - Full Text View

Sponsors and Collaborators:	University of New Mexico Schering-Plough
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00249964

Purpose

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

Condition	Intervention	Phase
Lung Diseases Cancer	Drug: Combination Paclitaxel, Carboplatin and Temozolomide	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Temozolomide Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

The maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin. The overall tumor response rate with this combination. [ Time Frame: Subjects will be followed in the clinic every four weeks to evaluate toxicity and tolerability. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The duration of response. [ Time Frame: The treatment will continue until 1) intolerable toxicity, 2) a total of six cycles of treatments has been given, 3) documented progression of tumor, 4) subject withdraw from the study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	November 2003
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Enrolled subjects will be receiving paclitaxel at dose of 175 mg/m2 and carboplatin at AUC of 5 on day 1 followed by starting dose of temozolomide at 75 mg/m2/day from day 2 to day 6, a total of 5 days for the first three subjects enrolled. Cycle length for the study is 21 days.

Subjects will be followed in the clinic every four weeks to evaluate toxicity and tolerability. The treatment will continue until 1) intolerable toxicity, 2) a total of six cycles of treatments has been given, 3) documented progression of tumor, 4) subject withdraw from the study.

Detailed Description:

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).

Eligibility

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

Criteria

Inclusion Criteria:

Age greater than or equal to 18 years
Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B)
Laboratory values (performed within 14 days prior to study drug administration, inclusive).
1. Absolute neutrophil count (ANC) >1500/mm3
2. Platelet count >100,000/mm3
3. Hemoglobin >10 g/dl or 100 g/l
4. BUN and serum creatinine <1.5 times upper limit of laboratory normal
5. Total and direct bilirubin <1.5 times upper limit of laboratory normal
6. SGOT and SGPT <3 times upper limit of laboratory normal
7. Alkaline Phosphatase <3 times upper limit of laboratory normal
A life expectancy of greater than 12 weeks
Subjects must give written informed consent.
Biopsy proven small cell lung cancer.
CT of chest, abdomen, pelvis and MRI of head
Patients with brain metastases should be asymptomatic to enter the study

Exclusion Criteria:

No recovery from all active toxicities of prior therapies.
Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
Concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
Known HIV positivity or AIDS-related illness.
Pregnant or nursing women.
Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
Men who are not advised to use an effective method of contraception.
Progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination.
Known hypersensitivity reaction to taxoid or platinum compound.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249964

Contacts

Contact: Valerie Parks

505-272-0898

VParks@salud.unm.edu

Locations

United States, New Mexico
University of New Mexico	Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Valerie Parks 505-272-0898 vparks@salud.unm.edu

Sponsors and Collaborators

University of New Mexico

Schering-Plough

Investigators

Principal Investigator:

Fa-Chyi Lee, MD

University of New Mexico

More Information

Responsible Party:	University of New Mexico - CRTC ( Fa-Chyi Lee, M.D.; Principal Investigator. )
Study ID Numbers:	0100C
Study First Received:	November 3, 2005
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00249964
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

Extensive or recurrent small cell lung cancer Phase I
Paclitaxel, Carboplatin, Temozolomide

Study placed in the following topic categories:

Carcinoma, Small Cell
Signs and Symptoms
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Temozolomide
Recurrence

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators

Antimitotic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009