Gemcitabine, Docetaxel, and Capecitabine in Treating Patients With Cancer of Unknown Primary Origin

NCT00119314 | Withdrawn Phase 2 DMC

• 6 other identifiers: CDR0000433512P30CA072720CINJ-000404CINJ-4735CINJ-NJ2203CINJ-5073
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel and capecitabine works in treating patients with cancer of unknown primary origin.

Conditions

Carcinoma of Unknown Primary

Keywords

newly diagnosed carcinoma of unknown primary; recurrent carcinoma of unknown primary

Interventions

capecitabine DRUG

docetaxel DRUG

gemcitabine hydrochloride DRUG

positron emission tomography PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignancy for which no primary origin has been identified despite routine workup, including the following: * History and physical examination * Chemistry profile and other blood work, including tumor markers with follow up on any positive findings * CT scan or MRI of the chest, abdomen, and pelvis * Mammography (for female patients) * Prostate examination (for male patients) * Stool guaiac * Measurable disease * Previously irradiated lesions are not considered measurable disease unless there is documented clear tumor progression in these lesions after completion of radiotherapy * The following tumor types or presentations are excluded: * Resectable disease * Tumors consistent with germ cell primary, as indicated by any of the following: * Midline tumor * Elevated beta human chorionic gonadotropin * Elevated alpha-fetoprotein * i12p chromosomal alteration * Prostate primary with elevated prostate-specific antigen * Females with axillary nodes as the primary disease site * Tumors limited to the peritoneal cavity consistent with primary peritoneal carcinoma * Neuroendocrine tumors * Squamous cell carcinoma involving cervical or inguinal lymph nodes * No symptomatic brain metastases * Prior brain metastases allowed provided patient completed definitive treatment with brain irradiation with or without resection PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * Hemoglobin ≥ 9.0 g/dL * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin normal * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit normal (ULN) * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST and ALT normal * Albumin ≥ 3.0 g/dL Renal * Creatinine ≤ 1.5 mg/dL Gastrointestinal * Able to take oral medication * Intestinal absorption intact * No uncontrolled diarrhea and/or daily emesis Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer * No severe medical or psychiatric illness that would preclude study treatment * No peripheral neuropathy \> grade 1 * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for this malignancy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * Prior palliative radiotherapy to areas of bony metastases allowed provided there is measurable disease outside the radiotherapy port * At least 4 weeks since prior radiotherapy * No prior radiotherapy to ≥ 25% of the bone marrow Surgery * See Disease Characteristics Other * No concurrent antiviral therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Cancer Center at the Mountainside Hospital

Montclair, New Jersey, 07042, United States

Location

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Hematology and Oncology Group

Somerset, New Jersey, 08873, United States

Location

Overlook Hospital

Summit, New Jersey, 07902-0220, United States

Location

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

Capecitabine; Docetaxel; Gemcitabine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Elizabeth A. Poplin, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2005
• First Posted: July 13, 2005
• Study Start: July 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: May 27, 2015

Record last verified: 2011-04

Locations

US (6)