Know Cancer

or
forgot password

Phase I/II Study of Oral Topotecan and Intravenous Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (Phases I and II) and Other Advanced Solid Tumors (Phase I Only)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase I/II Study of Oral Topotecan and Intravenous Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (Phases I and II) and Other Advanced Solid Tumors (Phase I Only)


OBJECTIVES: Phase I: I. Determine the maximum tolerated dose (MTD) of oral topotecan
combined with a fixed dose of paclitaxel in patients with advanced non-small lung cancer
(NSCLC) and other advanced solid tumors. II. Determine the response rate of NSCLC patients
treated at the MTD of oral topotecan combined with intravenous paclitaxel. III. Determine
the dose limiting toxicities of this drug combination in this patient population. Phase II:
IV. Determine the toxicities of this regimen at its MTD in patients with NSCLC. V. Determine
time to response, response duration, survival, time to progression, and rate of stable
disease of patients with NSCLC treated with this regimen at the MTD. VI. Assess changes in
well-being of patients with NSCLC treated with this regimen at the MTD.

OUTLINE: This is a dose escalation study of topotecan. Patients receive oral topotecan on
days 1-5 and paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the
absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive
escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
limiting toxicities. Once the MTD is determined, additional patients with non-small cell
lung cancer are accrued to receive treatment with topotecan and paclitaxel at the
recommended phase II dose. Quality of life is assessed in the phase II portion of the study
at baseline, before each treatment course, and at the end of the study. Patients are
followed at 3 weeks.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I dose escalation
portion of this study. A total of 14-40 additional non-small cell lung cancer patients will
be accrued to the phase II portion of this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Phase I: Advanced solid tumors, including non-small cell lung
cancer (NSCLC), that have failed conventional therapy or for which no standard effective
therapy exists May have failed conventional chemotherapy for tumor type Chemotherapy naive
NSCLC allowed Measurable or evaluable disease Phase II: Stage IIIB or IV NSCLC not
amenable to surgery or radiotherapy with curative intent No prior chemotherapy allowed At
least 1 bidimensionally measurable non-CNS indicator lesion defined by diagnostic studies
Measurable disease on CT or MRI scan must have one diameter at least 1 cm and one diameter
at least 2 cm Measurable disease on chest x-ray must have both diameters at least 2 cm
Palpable tumor masses that cannot be evaluated radiologically must have two diameters at
least 2 cm Measurable skin lesion must have at least one diameter at least 1 cm and its
presence must be evaluated by a photograph At least 6 weeks since prior radiotherapy to
measurable, progressive disease No brain and/or leptomeningeal metastases by CT or MRI
brain scan unless asymptomatic on neurologic exam and not receiving corticosteroid therapy
to control symptoms

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At
least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than
1.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Alkaline
phosphatase no greater than 1.5 times ULN (5 times ULN if liver metastases present) Renal:
Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception for 3 months prior to and during study Able to take oral medication No
active infection No other prior or concurrent malignancies except basal cell or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix No other severe medical
problem unrelated to malignancy that would preclude study compliance or expose patient to
extreme risk No condition of the gastrointestinal (GI) tract or otherwise that would
affect GI absorption and motility No history of hypersensitivity reactions to paclitaxel
or other drugs formulated in polyoxyethylated castor oil

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See
Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease
Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since
palliative radiotherapy and recovered No prior radiotherapy to greater than 30% of bone
marrow reserve No concurrent radiotherapy Surgery: See Disease Characteristics At least 4
weeks since prior surgery (lesser period acceptable if deemed in best interest of patient)
Other: No concurrent metoclopramide or cisapride to maintain motility or gastric emptying
At least 30 days or 5 half-lives since other prior investigational drugs for treatment of
cancer No other concurrent investigational medication

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert A. Figlin, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067543

NCT ID:

NCT00004979

Start Date:

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms

Name

Location