Combination Paclitaxel, Carboplatin and Temozolomide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00249964
First received: November 3, 2005
Last updated: September 18, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Lung Diseases
Cancer
Drug: Combination Paclitaxel, Carboplatin and Temozolomide
Phase 1

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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

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 ]

Enrollment: 15
Study Start Date: November 2003
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Combination Paclitaxel, Carboplatin and Temozolomide

    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:

  1. Age greater than or equal to 18 years
  2. Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B)
  3. 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
  4. A life expectancy of greater than 12 weeks
  5. Subjects must give written informed consent.
  6. Biopsy proven small cell lung cancer.
  7. CT of chest, abdomen, pelvis and MRI of head
  8. Patients with brain metastases should be asymptomatic to enter the study

Exclusion Criteria:

  1. No recovery from all active toxicities of prior therapies.
  2. Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
  3. Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
  4. 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.
  5. Known HIV positivity or AIDS-related illness.
  6. Pregnant or nursing women.
  7. 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.
  8. Men who are not advised to use an effective method of contraception.
  9. Progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination.
  10. Known hypersensitivity reaction to taxoid or platinum compound.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Fa-Chyi Lee, MD University of New Mexico
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00249964     History of Changes
Other Study ID Numbers: 0100C
Study First Received: November 3, 2005
Last Updated: September 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Extensive or recurrent small cell lung cancer Phase I
Paclitaxel, Carboplatin, Temozolomide

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Dacarbazine
Paclitaxel
Temozolomide
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014