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A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis


Phase 1
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis


OBJECTIVES:

Primary

- Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine
in patients with cervical carcinoma limited to the pelvis.

- Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin
and pelvic radiotherapy in these patients.

Secondary

- Determine the progression-free and overall survival of patients treated with
gemcitabine at the MTD in this regimen.

- Determine the site of recurrence, local versus distant, in patients treated with this
regimen.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine.

Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8,
15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients
also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27,
and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary
radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all
radiotherapy is not more than 8 weeks.

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients
experiences dose-limiting toxicity.

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

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-24
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary invasive carcinoma of the uterine cervix

- Previously untreated disease

- Any cell type

- Stage IB_2, IIA, IIB, IIIA, IIIB, or IVA

- Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is
suspicious for adenopathy

- No known metastases to scalene nodes or other organs outside the radiotherapy field

- Study enrollment within 8 weeks of diagnosis

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 normal

- SGOT no greater than 3 times normal

Renal

- Creatinine less than 2.0 mg/dL

- No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal
transplantation) that would require modification of radiotherapy fields

- No ureteral obstruction allowed unless treated with stent or nephrostomy tube

Other

- Not pregnant

- Fertile patients must use effective contraception

- No septicemia or severe infection

- No circumstance that would preclude study completion or follow-up

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior cytotoxic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior pelvic or abdominal radiotherapy

Surgery

- Not specified

Other

- No prior therapy for this malignancy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

MetroHealth Cancer Care Center at MetroHealth Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000327715

NCT ID:

NCT00068549

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical small cell carcinoma
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage IIB cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • Uterine Cervical Neoplasms

Name

Location
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043