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A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix


OBJECTIVES:

- Determine the antitumor activity of capecitabine in patients with persistent or
recurrent non-squamous cell carcinoma of the cervix who have failed higher priority
treatment protocols.

- Determine the nature and degree of toxicity of this drug in these patients.

- Determine whether the mRNA tumor expression levels of thymidylate synthase (TS),
dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) at baseline are
potential predictors of clinical outcomes (response and survival) in patients treated
with this drug.

- Determine whether the serum level of TP is a potential prognostic indicator of clinical
outcomes (response and survival) in patients treated with this drug.

- Determine whether the TS promoter polymorphism in peripheral blood is a potential
prognostic indicator of clinical outcomes (response and survival) in patients treated
with this drug.

- Determine the associations among the various measures of TS, DPD, and TP and clinical
outcomes (response and survival) in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 15-37 patients will be accrued for this study within
approximately 5-12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix

- Persistent or recurrent disease

- Eligible subtypes include:

- Adenocarcinoma

- Adenosquamous cell carcinoma

- Undifferentiated carcinoma

- Documented disease progression

- At least 1 unidimensionally measurable target lesion outside prior irradiation field

- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT
scan, and MRI) OR

- At least 10 mm by spiral CT scan

- Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent
non-SCC of the cervix

- Radiosensitizing chemotherapy administered in combination with primary
radiotherapy is not counted as a systemic chemotherapy regimen

- Tissue blocks from initial diagnosis, metastasis, or recurrence available for
submission to the GOG tissue bank

- Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol (if one
exists), defined as any Temporarily closed GOG phase III protocol for the same
patient population

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine clearance at least 50 mL/min

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No Temporarily closed infection requiring antibiotics

- No grade 2 or greater sensory or motor neuropathy

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biological or immunological anticancer agents

- No more than 1 prior non-cytotoxic biologic therapy or cytostatic regimen (e.g.,
monoclonal antibodies, cytokines, or small-molecule inhibitors of signal
transduction) for recurrent or persistent non-SCC of the cervix

Chemotherapy:

- See Disease Characteristics

- See Biologic therapy

- At least 3 weeks since prior chemotherapy and recovered

- No prior capecitabine

- No more than 1 prior cytotoxic chemotherapy regimen (either with single or
combination cytotoxic drug therapy)

Endocrine therapy:

- At least 1 week since prior hormonal anticancer therapy

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- Recovered from prior recent surgery

Other:

- At least 3 weeks since other prior anticancer therapy

- No prior cancer treatment that would preclude this study therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Katherine Y. Look, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069384

NCT ID:

NCT00039442

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Women's Cancer Center - Los GatosLos Gatos, California  95032
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
Hinsdale, Illinois  60521
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Cancer Institute of New Jersey at the Cooper University HospitalCamden, New Jersey  08103-1489
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009